First Quality Tissue Jobs in Usa

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Food Quality and Sanitation Manager
Salary not disclosed
Queens, NY 3 days ago

Food Safety Quality Assurance Manager


  • Bachelor's degree in Science
  • Food and beverage industry
  • Certifications: SQF Practitioner Certificate, HACCP and PCQI
  • In-depth knowledge of FDA regulations, ISO 9001, ISO 13485, and HACCP principles.
  • Strong experience in QA/QC processes including conducting quality audits.
  • Oversee daily, weekly, and deep-cleaning operations, ensuring equipment is properly sanitized and ready for production.



Are you looking to make a career change to a rapidly growing company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance and paid PTO. Does this position match your future career goals? Then this opportunity could be the right fit for you


Very Competitive Benefits Package

Excellent Growth and advancement opportunities


Employment Type:

Full-time


Job Requirements and Duties:

  • Bachelor's degree in Science
  • 5 plus years of food manufacturing industry experience
  • Certifications: SQF Practitioner Certificate, HACCP and PCQI
  • Preventive Controls Qualified Individual (PCQI) in accordance the Food Safety Modernization Act (FSMA) Preventive Controls for Human Food Rule
  • In-depth knowledge of FDA regulations, ISO 9001, ISO 13485, and HACCP principles.
  • Strong experience in QA/QC processes including conducting quality audits.
  • Manage the Food Fraud Program and Plant Security/Vulnerability Programs
  • Assist in New Customer Setups by verifying internal documentation matches customer specification requirements
  • Write, maintain, and improve quality system SOPs
  • Provide oversight and leadership of facility Quality Assurance team. Responsible for hiring and team member development
  • Manage the day to day operation of all quality function
  • Lead the team in the execution of HACCP plans and ensure proper documentation is maintained
  • Ensuring that manufacturing processes comply with standards at both National/ International level
  • Review SOPs & specifications
  • Oversee all aspects of daily quality operations
  • Manage budgeting
  • Ensure compliance with Federal, State and Local food safety regulations
  • Understanding of industry standards of Food Safety and Quality
  • Supports and participate to all the internal/external audits
  • Review test results
  • Provide, and oversee, inspection activity for product throughout production cycle
  • Apply total quality management tools and approaches to analytical and reporting processes
  • Schedule and coordinate preparations for product inspections and testing
  • Work to resolve noncompliance issues with materials or final product
  • Exceptional interpersonal skills and organizational skills


Benefits:

  • Great Pay
  • Very Competitive Benefits Package
  • Excellent work environment with growth opportunities
  • Immediate Hire



Jasleen Kaur

Ajulia Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a direct hire position that includes competitive compensation and full comprehensive benefit package.

#ZR

Not Specified
Director, Quality Affairs
Salary not disclosed
Farmington, MI 3 days ago

The Director Quality Affairs is in charge of providing subject matter expertise on matters related to FDA regulatory compliance requirements, as well as leading the growth and responsibilities of the Quality Department. Responsible for maintaining the company’s Quality Management System’s (QMS). The Director represents the company in key stakeholder and strategy meetings on all quality matters related the company’s assets (development and manufacturing), including meetings with executive leadership, meetings with FDA and other regulators, and working with development and manufacturing partners. This role combines scientific, regulatory, and business knowledge to assure that products are developed within GXP compliance while meeting the company’s strategic goals.


Essential Duties and Responsibilities:

Quality

  • Manages GXP quality activities.
  • Builds on the company’s Quality Management System; formulates the company’s GMP, GLP and GCP compliance strategies and provides advice and support for clinical development programs.
  • Oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, storage and distribution sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks.
  • Oversee the QA reviews of GMP manufacturing and packaging batch records, product release and stability testing, validation reports, and essential clinical study documents.
  • Assess all GMP compliance risks and develop and implement risk mitigation measures.
  • Develops and implements standards, policies and procedures for GMP, GLP and GCP compliance.
  • Partners with CMC, Clinical Development and Clinical Operations to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance.
  • Participates in the evaluation and selection of contract manufacturing sites, analytical testing sites, storage and distribution, CROs and other service providers used to support the clinical development programs.


Operations

  • As the company grows, build a strong quality team to meet the needs of the business.
  • Manage quality vendors.
  • Develop and mentor quality staff/personnel.


Supervisory Responsibilities:

  • Yes, in the future


Competencies:

To perform the job successfully, an individual should demonstrate the following competencies:

  • Over 10 years of progressive advancement within GMP, GLP and GCP in the pharmaceutical /biotech industry.
  • A thorough understanding of the drug development process along with knowledge of the developing regulations and guidelines.
  • Ability to speak and interact with a diverse group of individuals on technical and business topics.
  • Familiar with current regulatory legislation, industry trends, and health care business practices in the global arena.
  • Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization.
  • Strong presentation, written and verbal communication skills; a clear communicator who can influence stakeholders effectively, both internally and externally.
  • Proven ability to lead and manage complex global projects to successful completion.
  • Flexibility/agility to respond to Renew’s evolving business needs.
  • Strong ability to influence and gain credibility with both internal and external key stakeholders.
  • Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex Quality issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
  • Ability to build collaborative relationships both internally and externally.
  • Ability to inspire, motivate and develop regulatory and quality teams.
  • Ability to prioritize and handle multiple projects simultaneously.
  • Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with scientists, managers, peers, and staff.


Education and/or Experience:

  • BS/BA degree or equivalent (background in life sciences preferred). Advanced degree preferred.
  • 10 +yrs. of industry experience (biotech/pharma/ CRO) with at least 8 years of QA experience
  • Experience in ANDA and NDA FDA inspections (sponsor, vendor and sites)
  • Strong understanding of ICH, GMP, GCP and relevant regulatory requirements
  • Strong operations and management skills with attention to detail
  • Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project


Equal opportunity employer

Not Specified
Production And Quality Manager
Salary not disclosed
Chicago, IL 3 days ago

Growing manufacturing company that has been in business for over 40 years has an outstanding opportunity available in the Chicago metropolitan area for a Production & Quality Manager. This position will have 8 direct reports.

The Quality & Production Manager is responsible for leading all manufacturing, quality, and shipping operations to ensure safe, efficient, and compliant production that meets customer and business requirements. This role oversees daily shop operations, quality systems, inspection processes, and shipping performance while driving continuous improvement in productivity, scrap reduction, on-time delivery, and customer satisfaction.

This position is a hands-on leader who builds discipline, accountability, and process consistency within a fast-paced manufacturing environment.

Key Responsibilities

Production Leadership

  • Lead daily manufacturing operations to meet production schedules and delivery commitments
  • Supervise Production Team Lead and production staff; ensure appropriate training, performance management, and workforce planning
  • Monitor productivity, labor efficiency, and overtime
  • Identify and implement process improvements to improve throughput and reduce waste
  • Ensure compliance with safety policies and manufacturing standards

Quality Management

  • Own the company’s quality management system and inspection processes
  • Supervise Inspection/Quality Team Lead and inspection staff
  • Lead root cause analysis and corrective actions for customer complaints and internal non-conformances
  • Reduce scrap, rework, and quality-related costs
  • Ensure product conformance to customer specifications and regulatory requirements
  • Support continuous improvement initiatives


Shipping & Fulfillment

  • Oversee shipping operations to ensure accurate, timely, and compliant order fulfillment
  • Supervise shipping staff and coordinate workload priorities
  • Ensure proper documentation, labeling, packaging, and customer-specific requirements are met
  • Monitor on-time shipment performance and resolve delays proactively

Cross-Functional Coordination

  • Partner with Purchasing to ensure material availability aligns with production needs
  • Coordinate with Sales on production timing and feasibility
  • Collaborate with Data Analytics to track KPIs and drive data-based improvements

Performance & Metrics Ownership

  • Own KPIs including:
  • On-time delivery
  • Scrap and rework rates
  • Labor efficiency
  • Customer complaints
  • Report operational performance and improvement initiatives to senior leadership

Qualifications

  • 3-5+ years of manufacturing leadership experience
  • Demonstrated experience managing both production teams and quality systems
  • Experience supervising team leads or front-line supervisors
  • Strong understanding of root cause analysis and corrective action processes
  • Working knowledge of ERP systems
  • Ability to interpret technical drawings, specifications, and manufacturing instructions
  • Strong organizational and communication skills

Preferred

  • Experience in small to mid-sized manufacturing environments
  • Experience in ISO-certified environment
  • Background in process improvement methodologies (Lean, Six Sigma, etc.)

Experience in plastic injection molding, extrusion, thermoplastics, rubber, TPE, elastomers, blow molding, thermoforming, or polyolefins would be a plus.

At 3 years of manufacturing experience is a must. This position offers a very competitive base salary, bonus potential and comprehensive benefits.

Not Specified
Quality Engineer (Medical Device Manufacturing exp needed) - Germantown, WI
Salary not disclosed
Germantown, WI 3 days ago

Quality Engineer


As a Quality Engineer, you will assist with the development of quality systems, procedures and controls to ensure that all medical products consistently meet performance and quality specifications in the Germantown Manufacturing facility. The Quality Engineer is a leader and strong technical resource who quickly and effectively resolves quality problems with internal and external customers and suppliers.

Below Are Additional Duties And Responsibilities

  • Generates, communicates, and implements ideas and solutions.
  • Demonstrates accuracy and thoroughness in completing tasks timely.
  • Looks for ways to improve and promote quality.
  • Monitor Corrective Action System (i.e. Customer Complaints, Supplier, Internal)
  • Initiate and investigate Customer Complaints according to our internal procedure and standards.
  • Record essential information on internal and/or customer-specific documentation, including updating customer portals.
  • Perform investigations using Lean, Six Sigma, and statistical methods to support root cause analysis and corrective actions.
  • Identify gaps and/or trends in systems or processes.
  • Initiate and facilitate the Corrective/Preventative Action process using the appropriate quality tools and input from subject matter experts (SME) to implement sustainable solutions.
  • Update Quality documents according to our Change Control procedures, as required.
  • Verify corrective action effectiveness.
  • Drive Non-Conformance Process
  • Evaluate and investigate suspect non-conforming product identified by manufacturing and/or the Quality Lab.
  • Initiate containment activities, as necessary, with Customer Service and Shipping Department.
  • Recommend disposition of product based on thorough investigation and data-driven feedback.
  • Initiate and assist Customer Service with Return Material Authorization (RMA) process.
  • Develop re-inspection, sort, and/or rework instructions for Manufacturing Operators, as required.
  • Collaborate with customer on issuing waiver or deviation documentation and obtain customer approval, as required.
  • Maintain the Quality Management System (QMS).
  • Understand ISO 13485 Quality management systems requirements.
  • Ensure continuing compliance to both internal processes as well as requirements imposed by certification bodies, regulatory agencies, and specific customer requirements.
  • Assist in internal, 2nd party, and 3rd party audits.
  • Assist with responses and corrective actions for audit findings.
  • Support Product Realization process
  • Participate in design review, process planning, and failure mode analysis
  • Provide input on evaluation of Key Product Characteristics.
  • Provide input on gaging methods and equipment.
  • Interpret customer requirements including complex blueprints and GD&T call-outs.
  • Review and approve Engineering Change Notifications and Verifications
  • Evaluate for feasibility and implement updates to customer requirements into associated product control plans, pFMEA, Inspection documentation and other related documents.
  • Incorporate industry standard best practices.
  • Incorporate lessons learned.
  • Evaluate, submit and track Supplier Change Notices to customers and/or suppliers.
  • Any other duties as assigned.
  • Manufacturing point of contact for the review and disposition of product quality related questions.
  • Approve Medical Device release for shipment, as required.
  • Perform batch record reviews for medical device prior to release for shipment.
  • Generate Certificate of Analysis, as required.
  • Release product in ERP system based on customer and process requirements.
  • Support Manufacturing process
  • Train Manufacturing and Quality Control personnel on customer requirements, inspection techniques, lessons learned, and rework instructions.
  • Manage product inspection and testing activities.
  • Obtain customer approvals for all required changes based on Quality Agreements.
  • Compile supporting measurement and process performance data, as necessary
  • Assemble supporting documentation package and review for completeness and accuracy
  • Review and approve production documentation updates according to our Engineering Change Order process.
Not Specified
Global Quality Director
Salary not disclosed
Warren, MI 3 days ago

Global Quality Director – Warren, MI


Our client is seeking a Global Quality Director to lead quality strategy across operations. This role is responsible for ensuring compliance, driving continuous improvement, and aligning quality performance with customer and business expectations.


Why work here?


This organization offers a stable operating environment with a strong emphasis on operational excellence and continuous improvement. The company provides a competitive compensation and benefits package, along with opportunities for long-term growth and leadership impact within the organization.


Responsibilities:


The Global Quality Director is responsible for overseeing all aspects of operations quality, including:


  • Leading and developing the quality organization
  • Establishing and maintaining quality systems, policies, and procedures
  • Ensuring compliance with internal standards and customer requirements
  • Driving corrective and preventive actions
  • Overseeing root cause analysis and problem-solving activities
  • Monitoring key quality metrics and initiating improvement actions as required
  • Supporting audits and customer interactions related to quality performance
  • Partnering with internal customers to drive continuous improvement
  • Other duties as assigned


Experience:


  • Bachelor’s degree in Engineering, Quality, or a related technical discipline
  • 5+ years of experience in quality leadership roles


If you are interested in learning more, please apply to this posting.

Not Specified
Quality Control Manager – Packaging & Disposables
Salary not disclosed
Brewster, NY 2 days ago

Position Summary


The Quality Control Manager is responsible for ensuring that all packaging and consumable products purchased and distributed by Maadho meet company quality standards, regulatory requirements, and customer expectations. This role will proactively identify, investigate, and resolve quality issues while implementing preventive systems to maintain product consistency and compliance.


The ideal candidate has strong experience in food-service packaging and consumables, with a deep understanding of manufacturing standards, materials, and quality assurance processes.


Key Responsibilities


Quality Assurance & Inspection Audits

  • Develop, implement, and maintain quality control procedures for all incoming products and inventory.
  • Inspect food-service packaging and consumable products (e.g., gloves, cups, containers, cutlery, paper goods, bags) to ensure compliance with company and regulatory standards.
  • Establish product quality benchmarks and specifications for suppliers.


Supplier Quality Management

  • Work closely with domestic and international suppliers to communicate quality expectations.
  • Review and approve supplier specifications, certifications, and compliance documentation.
  • Coordinate corrective action plans with vendors when quality issues arise.
  • Conduct supplier performance evaluations and recommend improvements.


Issue Identification & Resolution

  • Track recurring issues and proactively recommend systemic improvements.
  • Investigate customer complaints and internal QC findings.
  • Perform root cause analysis on defective or non-conforming products.
  • Implement corrective and preventive actions (CAPA).

Qualifications Required

  • 3–5+ years of quality control experience in food-service packaging and consumables.
  • Strong knowledge of materials such as paper, plastics, compostables, foam, and food-contact packaging products.
  • Knowledge of FDA food-contact regulations and relevant industry standards including ISO Management
  • Experience working with manufacturers and suppliers on quality standards and compliance.
  • Proven ability to conduct root cause analysis and implement corrective actions.
  • Strong attention to detail and organizational skills.
  • Excellent communication skills with the ability to manage supplier relationships.
  • Proficiency in Microsoft Office (Excel, Word) and quality reporting systems.




Key Words: ACR, Amercareroyal, Karat Packaging, Injection Mold, Eco Products, Novolex, Pactiv, Paper Products,

Not Specified
Senior Quality Manager
Salary not disclosed
Morton Grove, IL 2 days ago

Position Description:


The Quality Manager will lead and oversee the Quality function at the Morton Grove site, ensuring compliance with GMP regulations, global quality standards, and customer expectations. This role will manage a team of Quality professionals and work closely with cross-functional departments to support the delivery of high-quality clinical and commercial batches.

The ideal candidate brings strong leadership skills, a solid understanding of CDMO business dynamics, and hands-on experience with clinical GMP manufacturing environments.


Role & Responsibilities:


  • Lead and manage the Quality Assurance and Quality Control teams at the site, as well as working with Global Regulatory Affairs for RA topics.
  • Ensure compliance with GMP regulations, global quality standards, and customer requirements for API manufacturing.
  • Oversee batch release activities, including review and approval of clinical and commercial GMP batches.
  • Develop, implement, and maintain Quality Systems (deviations, CAPA, change control, investigations, audits, etc.) to ensure a state of continuous compliance and inspection readiness.
  • Act as the primary quality contact for clients, regulatory authorities, and internal stakeholders for the site.
  • Support regulatory inspections and client audits; ensure timely and effective closure of observations.
  • Collaborate closely with Operations, Engineering, Regulatory Affairs, and Project Management to support manufacturing and technology transfer activities.
  • Drive continuous improvement initiatives to enhance quality performance and operational efficiency.
  • Manage and develop the Quality team through effective leadership, training, and performance management.
  • Contribute to the site’s strategic planning as part of the site leadership team.


Experience & Requirements:


  • Bachelor’s or master’s degree in chemistry, Pharmacy, Chemical Engineering, or related field.
  • Proven experience in a CDMO environment, working with multiple customers and projects.
  • Strong experience with clinical GMP batch manufacturing and release.
  • Previous experience managing and developing teams.
  • In-depth knowledge of ICH guidelines, GMP regulations (e.g., EU GMP, US FDA), and regulatory expectations.
  • Excellent communication skills and ability to interact effectively with internal and external stakeholders.
  • Strong problem-solving and decision-making skills
  • Minimum 5 years of experience in Quality roles within the pharmaceutical or chemical API industry.
Not Specified
Quality Assurance Engineer II - Manufacturing
Salary not disclosed
Freedom, PA 2 days ago

Join the MEPPI Team!

Mitsubishi Electric Power Products, Inc. (MEPPI) is seeking a Quality Assurance Engineer II - Manufacturing to plan, direct and support activities to assess and provide for root cause analysis and corrective action implementation for Transportation Systems Division (TSD) quality problems. Implement and maintain quality assurance programs and lead efforts with internal audits.


This position will report to the TSD Quality Assurance Section Manager and is an onsite position in Freedom, PA.


What You’ll Do:

  • Participate in and/or lead supplier validation audits using product quality planning tools.
  • Collaborate with suppliers to investigate quality problems, identify root causes of problems, develop correction action plans and implement improvements. Verify corrective actions are implemented and maintained.
  • Serve as a quality assurance liaison to Japan. Learn and implement applicable Japanese techniques for quality assurance improvements.
  • Participate in the development of new products or modifications of existing products to meet customer requirements.
  • Participate in and/or lead internal audits. Work with all departments to help close audit findings in an effective and timely manner.
  • Coordinate continued evaluation of procedures and documentation throughout TSD. Verify for completeness, accuracy and lack of redundancy.
  • Facilitate in-house quality assurance and manufacturing improvement programs throughout TSD.
  • Assure quality records are generated, retained, stored, protected and disposed of according to TSD and Company policies.


What You’ll Bring:

  • Bachelor’s Degree in Engineering or related technical field with 3-5 years of experience in quality control and/or assurance function, or equivalent education and experience.
  • Advanced knowledge of QA and manufacturing improvement practices such as Lean Six Sigma and Black Belt and an understanding of the underlying philosophy.
  • Advanced knowledge of quality techniques such as Statistical Process Control, Deming Methods, 5-Why, 8DS, etc.
  • Advanced interpersonal communication and presentation skills required to communicate with customers, vendors and employees.
  • Advanced analytical and problem-solving skills.
  • Advanced computer skills with emphasis on MS Office products and MRP/ERP systems.


What’s in It for You:

Comprehensive Health Coverage:

  • MEPPI pays up to 90% of the cost for medical, dental, and vision plans.

Retirement Plans:

  • 401(k) match of up to 4%.

Generous Paid Time Off:

  • Earn vacation after just 90 days, plus enjoy 12 paid holidays annually.

Career Growth:

  • Access to professional development programs and educational assistance.

Employee Perks:

  • On-site fitness center (Warrendale, PA), wellness program, profit sharing, and employee discounts.


Why MEPPI:

As a proud U.S. affiliate of Mitsubishi Electric, MEPPI powers critical infrastructure and rail transportation solutions across North America. We value collaboration, innovation, and people—because we know that our greatest asset is our team. Join us and help shape a future where talent and technology thrive


Equal Opportunity Employer:

MEPPI is committed to diversity and inclusion in the workplace. We welcome applicants from all backgrounds and ensure fair consideration for every candidate.


Notice to Agencies and Search Firms:

We do not accept unsolicited resumes from agencies. Submissions without signed agreements become the property of MEPPI, and no fees will be paid.


Applicants are considered for all positions without regard to race, color, religion, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, marital status, national origin, ancestry, age, physical or mental disability or (as defined by applicable law) medical condition or genetic information, military or veteran status or any other legally protected status.


Notice to Agency and Search Firm Representatives: Mitsubishi Electric Power Products, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Mitsubishi Electric Power Products, Inc. employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Mitsubishi Electric Power Products, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Not Specified
Director Quality Systems
Salary not disclosed
Princeton, NJ 2 days ago

About Made Scientific

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.


Position Summary

The Director, Quality Systems is a hands-on leadership role responsible for leading the development, design, and maintenance of the Quality Management System (QMS). This role will oversee the implementation and continuous improvement of the QMS to maximize efficiency, effectiveness, and compliance with all applicable GxP regulations and client requirements and expectations.


Key Responsibilities

• Develop and maintain the Site Quality Management System and provide ongoing assessment of QMS effectiveness through Quality Management Review (QMR) and other established monitoring programs and processes.

• Identify, execute, and manage quality improvement initiatives to continually improve efficiency, effectiveness, and compliance with applicable cGMP regulations and client requirements.

• Support the development of company objectives and ensure Quality Plan initiatives are properly planned, prioritized, resourced, executed, and evaluated for effectiveness.

• Direct the Quality Management Review process, including oversight of analysis and reporting of Quality System performance metrics.

• Identify compliance gaps and improvement opportunities to inform the Site Quality Plan and inspection readiness strategies.

• Co-lead the Internal Audit program with the Head of Inspection Readiness, including oversight of audit schedules and ensuring appropriate follow-up in alignment with internal procedures, regulatory expectations, client requirements, and auditing best practices.

• Manage the CAPA system, ensuring root causes are clearly identified and addressed through robust corrective actions to prevent recurrence, and that actions are evaluated for effectiveness post-implementation.

• Establish and manage GMP training programs to ensure training requirements align with job functions and job descriptions.

• Collaborate with the Head of Inspection Readiness to coordinate activities related to regulatory and client inspections (announced or unannounced), including preparing documentation, identifying potential compliance gaps, and managing inspection logistics.

• Support post-inspection response activities, including drafting responses, coordinating updates, and ensuring follow-up actions are implemented within the QMS.

• Provide input into regulatory inspection responses to ensure systemic and comprehensive solutions address root causes and prevent recurrence.

Leadership & People Management

• Mentor and coach team members to continually develop and enhance their skills.

• Lead by demonstrating the company values of standing shoulder to shoulder, owning it always, breakthrough thinking, and competing where it counts.

• Foster a culture of accountability with progressive empowerment and ownership.

• Promote a culture that values innovation, continuous improvement, and personal accountability across the organization.


Required Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, or a related scientific discipline.

• 10–12 years of cGMP or Quality experience, including prior supervisory or team leadership experience; or a Master’s degree with 5–7 years of relevant experience.

• Experience hosting and managing regulatory and client inspections.

• Strong understanding of Quality Systems requirements and regulatory expectations.

• Excellent oral and written communication, listening, and problem-solving skills.

• In-depth knowledge of regulated activities, health authority expectations, GxP, and Quality Risk Management.

• Strong organizational awareness with significant experience working cross-functionally.

• Experience developing and executing large-scale organizational change initiatives, including change management strategies and planning.

• Demonstrated ability to understand complex processes and facilitate teams toward effective solutions.

• Ability to design and implement global business processes and policies with a strategic and enterprise mindset.

• Proven experience influencing stakeholders across a broad spectrum of GxP topics.

• Flexibility to support varying work schedules, including evenings, weekends, or holidays as needed.


Preferred Qualifications

• In-depth knowledge of cGMP regulations and the ability to apply them in compliance with U.S., EU, and global regulatory standards.

• Experience with cell and gene therapy manufacturing in clinical or commercial environments.

• Strong track record managing quality systems and training programs.

• Expertise in aseptic manufacturing processes.

• Demonstrated ability to foster collaboration, influence cross-functional teams, and drive cultural and operational improvements.

• Innovative mindset with the ability to adapt best practices within a fast-paced, growing organization.


Required Degree

• B.S. in a relevant scientific discipline (advanced degree preferred).


Physical Requirements

Ability to perform job functions in compliance with applicable standards, including productivity and attendance expectations. Must be flexible to work in various environments, including gowning for aseptic processing facilities, lifting up to 25 lbs., and performing physical tasks such as bending, standing, and working with cell-based products or chemicals.

Not Specified
Director of Quality Initiatives
Salary not disclosed
Queens, NY 2 days ago

About NYC Health + Hospitals


NYC Health + Hospitals is the largest public health care system in the nation. We are a network of 11 hospitals, trauma centers, neighborhood health centers, nursing homes, post-acute care centers, and correctional health services. We are a home care agency and a health plan, MetroPlus. Our health system provides essential services to 1.4 million New Yorkers every year in more than 70 locations across the city's five boroughs. Our diverse workforce of more than 42,000 employees are uniquely focused on empowering New Yorkers.


NYC Health + Hospitals/Correctional Health Services is one of the nation’s leading correctional health care systems in quality of and innovations to care, and access from pre-arraignment through compassionate release. In-jail services include medical, nursing, mental health, substance use treatment, social work, dental and vision care, discharge planning, and reentry support. In addition to providing direct patient care in the jails, CHS leverages the resources of the nation’s largest municipal health care system to help discharged patients successfully return to their communities. CHS is also a pivotal partner in New York City’s criminal justice reform efforts.


Work Shifts


  • 9:00 A.M – 9:00 P.M
  • Various Location at Rikers Island


Duties & Responsibilities


Summary of position: (Position Description)

Reporting to the Chief of Medicine, the Director of Quality Initiatives will serve as a central point of supervision for quality initiatives with wide latitude to participate in programmatic quality improvement and quality assurance work across the CHS Medicine service. The Director of Quality Initiatives will function as a part of the medicine service and support initiatives to improve care across the service. The role will involve developing a deep understanding of workflows and operations of the CHS Medicine service and working across disciplines to coordinate quality initiatives, analyze data, and support presentations.

Responsibilities include: (Detailed Task)

  • In coordination with CHS Medicine leadership and CHS IT Health Information unit, manage data and presentations for Medicine quality improvement committee (QIC) meetings.
  • Maintenance and dissemination of monthly quality Improvement dashboard.
  • Coordinate facility-based quality improvement meetings to provide direct feedback to Medicine service clinical staff.
  • Coordinate with the Compliance and Health Information unit and Medicine service leadership to meet Medicine QIC and NYC H+H Quality Assurance Performance Improvement (QAPI) obligations.
  • Track and support completion of Performance Improvement Projects that meet specific quality goals.
  • Work with CHS Medicine leadership to share findings within CHS and externally where appropriate.
  • Learn clinical and operational workflows of care delivery in the New York City jails in order to identify areas for focused improvement initiatives.
  • Liaise between Medicine leadership, IT and other departments on new reports and initiatives.
  • Collaborate in implementing new and revising existing quality improvement projects.
  • Participate in other data projects and tasks as requested.
  • Cross-cover Medicine Service central administrative team (including Medicine Special Assistant, Director of Medical Administration, and Director of Clinical Education) to meet service goals and support administrative needs of service leadership.


Minimum Qualifications


1. A Master’s degree from an accredited college or university in Public Administration, Public Health, Business Administration, or a related discipline, and one (1) year of full-time experience in an administrative capacity in business management systems, general administration, health care or medical/patient systems administration; or,

2. A Baccalaureate Degree from an accredited college or university in Public Administration, Public Health, Business Administration, or a related discipline, and two (2) years of full-time experience in an administrative capacity in business management systems, general administration, health care or medical/patient systems administration.


Department Preferences


  • Master's Degree in Public Health, Master's Degree in Public Administration, or related degree with a concentration on quantitative and/or qualitative analysis.
  • Experience working within correctional settings on academic, research, or data-driven projects.
  • Strong data/statistical analysis and database management skills;
  • Advanced knowledge of Windows and Microsoft Office Suite and familiarity with standard statistical software packages (SPSS, SAS, etc.);
  • Interest in correctional healthcare;
  • Excellent interpersonal communication skills and ability to work collaboratively with other disciplines, including DOC staff;
  • Strong organizational, project management, and multitasking abilities.


Benefits


NYC Health and Hospitals offers a competitive benefits package that includes:

  • Comprehensive Health Benefits for employees hired to work 20+ hrs. per week
  • Retirement Savings and Pension Plans
  • Paid Holidays and Vacation in accordance with employees' Collectively bargained contracts
  • Loan Forgiveness Programs for eligible employees
  • College tuition discounts and professional development opportunities
  • College Savings Program
  • Union Benefits for eligible titles
  • Multiple employee discounts programs
  • Commuter Benefits Programs
Not Specified
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