Tg Gallagher Jobs in Usa

Role: Project Director – Data Centre and Pharmaceutical Construction

Location: Houston, Texas

Job Type: Full Time / Permanent

Salary: $200,000 - $250,000 + benefits

We are working with a leading international design and build contractor specialising in mission-critical infrastructure, delivering complex data centre projects for hyperscale and enterprise clients across North America and Europe.

Due to continued growth in the North American market, they are seeking an experienced Project Director to lead the delivery of large-scale data centre construction programmes.

This is a senior leadership role responsible for driving the successful delivery of hyperscale and mission-critical facilities, overseeing projects from early pre-construction through to commissioning and handover.

What you’ll be doing

• Leading the delivery of large-scale data centre construction projects and programmes
• Setting project delivery strategy across design, procurement, construction and commissioning
• Acting as the senior point of contact for hyperscale and enterprise clients
• Leading multidisciplinary project teams across construction, engineering, commercial and planning functions
• Managing project financial performance including budgets, forecasting and cost control
• Ensuring projects are delivered safely, on programme and to the required quality standards
• Managing supply chain partners and specialist contractors across complex technical packages
• Identifying and mitigating project risks across commercial, operational and delivery areas
• Leading executive project reviews and reporting progress to senior leadership and client stakeholders
• Supporting pre-construction strategy and bid development for future data centre projects

What we’re looking for

• 15+ years’ experience delivering major construction projects
• Proven leadership on large-scale data centre or mission-critical infrastructure projects
• Experience working with hyperscale, colocation or enterprise data centre clients
• Strong experience managing large project teams and complex contractor supply chains
• Solid commercial awareness with experience managing project budgets and financial performance
• Strong stakeholder and client relationship management skills
• Degree in Construction Management, Engineering or a related discipline preferred

What you’ll bring

• Strategic leadership across large and complex data centre programmes
• Strong commercial and contractual understanding within construction environments
• The ability to lead multidisciplinary teams within technically demanding projects
• A proactive approach to project risk, programme delivery and performance management
• A leadership style that drives accountability, collaboration and project excellence

Project Engineer

$100,000 - $110,000

Location: Houston, Texas, United States - will be required to travel

Position Overview

An established engineering and construction organisation is seeking a Project Engineer to support the planning, coordination, and execution of construction projects.

This role acts as a key link between design teams and site operations, ensuring that engineering, technical, and documentation requirements are effectively managed throughout the project lifecycle. The Project Engineer will work closely with project management, site teams, subcontractors, and clients to help deliver projects safely, on schedule, and within budget.

Key Responsibilities

• Support the Project Manager in overall project delivery, including planning, scheduling, and project documentation.
• Review drawings, specifications, and technical submittals to ensure compliance with project requirements.
• Coordinate between engineering, procurement, and construction teams to resolve technical queries and design issues.
• Manage Requests for Information (RFIs), submittals, and document control processes.
• Assist with cost estimates, quantity take-offs, and material tracking.
• Monitor project progress against the construction schedule and flag potential risks or delays.
• Participate in project meetings and maintain accurate records of discussions and actions.
• Provide technical support to site teams, ensuring construction aligns with approved drawings and specifications.
• Track design changes, scope variations, and revisions throughout the project lifecycle.
• Support project close-out activities including as-built drawings, handover documentation, and commissioning records.
• Promote and maintain high safety and quality standards across all project activities.

Qualifications

• Bachelor’s degree in Construction Management, Civil Engineering, or a related discipline.
• 0–3 years of experience in construction engineering, project coordination, or similar roles (industrial, commercial, or infrastructure projects preferred).
• Good understanding of construction drawings, specifications, and project delivery processes.
• Experience with construction management software such as Procore, Bluebeam, CMiC, or Primavera is beneficial.
• Strong communication, organisational, and time management skills.
• Excellent problem-solving ability and attention to detail.
• Ability to work collaboratively with multi-disciplinary project teams.

Working Conditions

• Combination of office-based and site-based work depending on project stage.
• Ability to visit active construction sites as required.
• Occasional travel may be required depending on project locations.

Senior Project Manager - Data Centres

$170,000 - €205,000 + Package

Dallas Based - Travel to other states required

Position Overview

The Senior Project Manager is responsible for leadership and oversight of large or complex construction projects from preconstruction through closeout. This role ensures projects are delivered safely, on time, within budget, and to the required quality standards, while managing multiple teams and maintaining strong client relationships.

Key Responsibilities

Project Leadership & Execution

• Lead planning, execution, and delivery of large-scale or multi-phase construction projects.
• Oversee project schedules, budgets, and cost control systems.
• Ensure adherence to design specifications, contract terms, and company standards.
• Manage procurement processes, including subcontractor selection and contract negotiations.
• Monitor performance metrics for cost, quality, and schedule, addressing risks and variances proactively.

Financial & Contract Management

• Maintain project budgets, cash flow projections, and cost forecasts.
• Review, negotiate, and administer contracts with owners and subcontractors.
• Approve progress payments, change orders, and invoices.
• Maintain profitability while ensuring client satisfaction and operational compliance.

Team Leadership & Development

• Lead and mentor project managers, site superintendents, and support teams.
• Build high-performing teams focused on collaboration, accountability, and results.
• Support staff growth through coaching, training, and performance feedback.
• Promote alignment between field operations and project management.

Client & Stakeholder Management

• Serve as the primary point of contact for clients, consultants, and project partners.
• Lead progress meetings and maintain proactive communication with stakeholders.
• Manage expectations and develop long-term client relationships.
• Participate in business development and preconstruction presentations.

Safety & Quality

• Champion safety culture and ensure compliance with safety programs and regulations.
• Oversee project quality plans, inspections, and testing.
• Ensure corrective actions are promptly implemented for deficiencies or safety incidents.

Preconstruction & Strategic Input

• Collaborate with estimating and preconstruction teams for budgets and constructability reviews.
• Provide input during design and value engineering phases to optimize cost and efficiency.
• Contribute to company-wide process improvement and project delivery strategies.

Qualifications

• Diploma or degree in Construction Management, Civil Engineering, or equivalent experience.
• 3–5 years of construction experience in field coordination, site supervision, or similar role.
• Strong knowledge of construction methods, sequencing, and site safety practices.
• Ability to read and interpret blueprints, drawings, and specifications.
• Proficiency with construction software (e.g., Procore, CMiC, Viewpoint, Bluebeam).
• Excellent communication, organization, and leadership skills.
• Valid driver’s license and ability to travel to project sites.
• Safety certifications such as OSHA 30, CSO, COR, or equivalent preferred.

Role: VP of Construction – Data Centre and Pharmaceutical Construction

Location: Houston, Texas

Job Type: Full Time / Permanent

Salary: $200,000 - $250,000 + benefits

We are working with a leading international design and build contractor specialising in mission-critical infrastructure, delivering complex data centre projects for hyperscale and enterprise clients across North America.

Due to continued growth in the North American market, they are seeking an experienced Project Director to lead the delivery of large-scale data centre construction programmes.

This is a senior leadership role responsible for driving the successful delivery of hyperscale and mission-critical facilities, overseeing projects from early pre-construction through to commissioning and handover.

What you’ll be doing

• Leading the delivery of large-scale data centre construction projects and programmes
• Setting project delivery strategy across design, procurement, construction and commissioning
• Acting as the senior point of contact for hyperscale and enterprise clients
• Leading multidisciplinary project teams across construction, engineering, commercial and planning functions
• Managing project financial performance including budgets, forecasting and cost control
• Ensuring projects are delivered safely, on programme and to the required quality standards
• Managing supply chain partners and specialist contractors across complex technical packages
• Identifying and mitigating project risks across commercial, operational and delivery areas
• Leading executive project reviews and reporting progress to senior leadership and client stakeholders
• Supporting pre-construction strategy and bid development for future data centre projects

What we’re looking for

• 15+ years’ experience delivering major construction projects
• Proven leadership on large-scale data centre or mission-critical infrastructure projects
• Experience working with hyperscale, colocation or enterprise data centre clients
• Strong experience managing large project teams and complex contractor supply chains
• Solid commercial awareness with experience managing project budgets and financial performance
• Strong stakeholder and client relationship management skills
• Degree in Construction Management, Engineering or a related discipline preferred

What you’ll bring

• Strategic leadership across large and complex data centre programmes
• Strong commercial and contractual understanding within construction environments
• The ability to lead multidisciplinary teams within technically demanding projects
• A proactive approach to project risk, programme delivery and performance management
• A leadership style that drives accountability, collaboration and project excellence

Project Engineer

$100,000 - $110,000

Location: Dallas / Houston, Texas, United States - will be required to travel

Position Overview

An established engineering and construction organisation is seeking a Project Engineer to support the planning, coordination, and execution of construction projects.

This role acts as a key link between design teams and site operations, ensuring that engineering, technical, and documentation requirements are effectively managed throughout the project lifecycle. The Project Engineer will work closely with project management, site teams, subcontractors, and clients to help deliver projects safely, on schedule, and within budget.

Key Responsibilities

• Support the Project Manager in overall project delivery, including planning, scheduling, and project documentation.
• Review drawings, specifications, and technical submittals to ensure compliance with project requirements.
• Coordinate between engineering, procurement, and construction teams to resolve technical queries and design issues.
• Manage Requests for Information (RFIs), submittals, and document control processes.
• Assist with cost estimates, quantity take-offs, and material tracking.
• Monitor project progress against the construction schedule and flag potential risks or delays.
• Participate in project meetings and maintain accurate records of discussions and actions.
• Provide technical support to site teams, ensuring construction aligns with approved drawings and specifications.
• Track design changes, scope variations, and revisions throughout the project lifecycle.
• Support project close-out activities including as-built drawings, handover documentation, and commissioning records.
• Promote and maintain high safety and quality standards across all project activities.

Qualifications

• Bachelor’s degree in Construction Management, Civil Engineering, or a related discipline.
• 0–3 years of experience in construction engineering, project coordination, or similar roles (industrial, commercial, or infrastructure projects preferred).
• Good understanding of construction drawings, specifications, and project delivery processes.
• Experience with construction management software such as Procore, Bluebeam, CMiC, or Primavera is beneficial.
• Strong communication, organisational, and time management skills.
• Excellent problem-solving ability and attention to detail.
• Ability to work collaboratively with multi-disciplinary project teams.

Working Conditions

• Combination of office-based and site-based work depending on project stage.
• Ability to visit active construction sites as required.
• Occasional travel may be required depending on project locations.

We are seeking a highly skilled and detail-oriented P&ID Designer or Process Engineer to join our engineering team. The ideal candidate will have hands-on experience in creating and revising Piping and Instrumentation Diagrams (P&IDs) using AutoCAD, Revit, and Plant 3D, with a strong understanding of ISO and industry standards. This role is critical to ensuring accurate documentation of process systems for industrial, manufacturing, or energy projects.

Key Responsibilities:

• Design and revise P&IDs for process systems in compliance with ISO and project-specific standards.
• Collaborate with mechanical, electrical, and process engineers to ensure accurate system representation.
• Use AutoCAD Plant 3D and Revit to model piping layouts, instrumentation, and equipment.
• Maintain and update engineering documentation, including BOMs, datasheets, and control narratives.
• Conduct quality checks and ensure drawings meet regulatory and safety requirements.
• Support project teams during design reviews, construction, and commissioning phases.
• Integrate P&IDs with 3D models and databases for intelligent documentation and asset tracking.

Qualifications:

• Bachelor’s degree in mechanical, Chemical, or Industrial Engineering (or equivalent experience).
• 3+ years of experience in P&ID design or process engineering.
• Proficiency in AutoCAD, Revit, and Plant 3D.
• Strong knowledge of ISO standards and ANSI/ISA instrumentation symbols.
• Familiarity with process control systems and industrial equipment.
• Excellent attention to detail and organizational skills.
• Strong communication and collaboration abilities.

Preferred Skills:

• Experience with SmartPlant P&ID or AVEVA Diagrams.
• Knowledge of BIM workflows and integration.
• Understanding of process safety and HAZOP documentation.
• Ability to automate tasks using scripts or macros in CAD environments.

• Provides medical management to workers compensation injured employees. Performs case management through telephonic contact with all medical providers, employers, claims professionals and ancillary service providers.
• Manage medical care in order to return injured employee to preinjury status. 
• Reviews services of medical and rehabilitation providers and arranges for and coordinates appropriate evaluation, treatment, and counseling.
• Communicates with physician, injured worker, employer, referral source, and any other resource involved in worker's rehabilitation program.
• Evaluates home care services and equipment and determines need for home modifications. Coordinates home care.
• Communicates with employers to determine job requirements of pre-injury occupation and to explore light-duty, modified, or alternate employment as necessary.
• Analyzes results of treatment and medical status and reviews incoming provider reports.
• Identifies suitable employment opportunities consistent with individual's medical limitations/capabilities, aptitudes, and interests to restore individual to maximum independence.
• Generates reports to referral source to communicate case status, findings, and recommendations.
• Generates correspondence to referral source, medical providers, injured worker and other parties involved in the rehabilitation process.
• Participates in case conferences over the telephone, and participates in internal and external training to enhance and maintain medical proficiency. Documents case management observations, assessment, and plan in system.
• Must maintain a case load to support at minimum 145 hours of billable or inventory of minimum of 72 files monthly with 95% Quality compliance expected.

Required: Degree from applicable program of training and a minimum of 3 years clinical experience in an acute care setting required. Active Registered Nursing license or equivalent within the state of practice or states in which CM is performed 

Preferred: Bachelor's degree preferred. Worker's Compensation experience is preferred. Certification in related field preferred.

Behaviors: Demonstrates adequate knowledge of managed care with emphasis on use of criteria , guidelines and national standards of practice. Demonstrates good written and oral communications, organizational and leadership skills. Computer literate. Demonstrates good time management skills. Self starter.

We offer a competitive and comprehensive compensation package. The base salary range represents the anticipated low end and high end of the range for this position. The actual compensation will be influenced by a wide range of factors including, but not limited to previous experience, education, pay market/geography, complexity or scope, specialized skill set, lines of business/practice area, supply/demand, and scheduled hours. On top of a competitive salary, great teams and exciting career opportunities, we also offer a wide range of benefits. 

Below are the minimum core benefits you’ll get, depending on your job level these benefits may improve:

• Medical/dental/vision plans, which start from day one!
• Life and accident insurance
• 401(K) and Roth options
• Tax-advantaged accounts (HSA, FSA)
• Educational expense reimbursement
• Paid parental leave

Other benefits include:

• Digital mental health services (Talkspace)
• Flexible work hours (availability varies by office and job function)
• Training programs
• Gallagher Thrive program – elevating your health through challenges, workshops and digital fitness programs for your overall wellbeing
• Charitable matching gift program
• And more...

**The benefits summary above applies to fulltime positions. If you are not applying for a fulltime position, details about benefits will be provided during the selection process.

We value inclusion and diversity

Click Here to review our U.S. Eligibility Requirements

Inclusion and diversity (I&D) is a core part of our business, and it’s embedded into the fabric of our organization. For more than 95 years, Gallagher has led with a commitment to sustainability and to support the communities where we live and work.

Gallagher embraces our employees’ diverse identities, experiences and talents, allowing us to better serve our clients and communities. We see inclusion as a conscious commitment and diversity as a vital strength. By embracing diversity in all its forms, we live out The Gallagher Way to its fullest.

Gallagher believes that all persons are entitled to equal employment opportunity and prohibits any form of discrimination by its managers, employees, vendors or customers based on race, color, religion, creed, gender (including pregnancy status), sexual orientation, gender identity (which includes transgender and other gender non-conforming individuals), gender expression, hair expression, marital status, parental status, age, national origin, ancestry, disability, medical condition, genetic information, veteran or military status, citizenship status, or any other characteristic protected (herein referred to as “protected characteristics”) by applicable federal, state, or local laws.

Equal employment opportunity will be extended in all aspects of the employer-employee relationship, including, but not limited to, recruitment, hiring, training, promotion, transfer, demotion, compensation, benefits, layoff, and termination. In addition, Gallagher will make reasonable accommodations to known physical or mental limitations of an otherwise qualified person with a disability, unless the accommodation would impose an undue hardship on the operation of our business.

Primarily focused on applying medical knowledge and research, in a legal setting, to advise in the review and analysis of medical malpractice claims.  Collaborates with claims handling professionals and attorneys to identify and evaluate liability and causation issues to assist in the defense of healthcare provider defendants in medical malpractice litigation. 

Key Responsibilities:

• Conducting thorough medical malpractice case reviews, including reviewing and analyzing medical records; Preparing detailed medical chronologies, summaries, and reports for use in legal proceedings; Participating in the review and/or preparation of legal documents, including pleadings, motions, and discovery requests related to medical issues; Coordinating and communicating with opposing counsel and expert witnesses to gather necessary information and expert opinions; and Reviewing and analyzing medical literature, research studies, and industry standards to support legal arguments and strategies.
• Attends meetings, depositions, and trials to provide medical expertise and support to attorneys.
• Collaborates with the legal team to develop case strategies, conduct legal research, and assist in trial preparation.

Required:

• Bachelor's degree in Nursing (BSN) or equivalent; Registered Nurse (RN) license is required.
• Minimum of 3 years of clinical nursing experience.
• Must have proficient knowledge of medical malpractice and personal injury law.
• Strong knowledge of medical terminology, healthcare regulations, and legal procedures.
• Excellent research and analytical skills, with the ability to interpret complex medical information and apply it to legal cases.
• Proficient in using medical research databases, electronic medical record systems, and legal research tools.
• Excellent written and verbal communication skills, with the ability to effectively communicate complex medical concepts to claims handling professionals, attorneys and other team members.
• Proficient in using Microsoft Office Suite (Word, Excel, PowerPoint) and legal case management software. Strong Analytical and interpretive skills. 
• Ability to create and complete comprehensive, accurate and constructive written reports.

Desired:

• Experience in a hospital or medical-legal setting preferable.
• Paralegal certification or equivalent legal education and experience is highly desirable.
• Prior experience working for a law firm, insurance company, third party claims administrator or in-house legal team assisting in the management and defense of medical malpractice litigation is strongly preferred.

Work Traits:

• Strong ethical standards and commitment to maintaining confidentiality.
• Stays updated and abreast on current healthcare regulations, industry trends, and legal developments related to medical malpractice and personal injury cases.
• Maintains strict confidentiality of all medical and legal information in accordance with all applicable regulations.

We offer a competitive and comprehensive compensation package. The base salary range represents the anticipated low end and high end of the range for this position. The actual compensation will be influenced by a wide range of factors including, but not limited to previous experience, education, pay market/geography, complexity or scope, specialized skill set, lines of business/practice area, supply/demand, and scheduled hours. On top of a competitive salary, great teams and exciting career opportunities, we also offer a wide range of benefits. 

Below are the minimum core benefits you’ll get, depending on your job level these benefits may improve:

• Medical/dental/vision plans, which start from day one!
• Life and accident insurance
• 401(K) and Roth options
• Tax-advantaged accounts (HSA, FSA)
• Educational expense reimbursement
• Paid parental leave

Other benefits include:

• Digital mental health services (Talkspace)
• Flexible work hours (availability varies by office and job function)
• Training programs
• Gallagher Thrive program – elevating your health through challenges, workshops and digital fitness programs for your overall wellbeing
• Charitable matching gift program
• And more...

**The benefits summary above applies to fulltime positions. If you are not applying for a fulltime position, details about benefits will be provided during the selection process.

We value inclusion and diversity

Click Here to review our U.S. Eligibility Requirements

Inclusion and diversity (I&D) is a core part of our business, and it’s embedded into the fabric of our organization. For more than 95 years, Gallagher has led with a commitment to sustainability and to support the communities where we live and work.

Gallagher embraces our employees’ diverse identities, experiences and talents, allowing us to better serve our clients and communities. We see inclusion as a conscious commitment and diversity as a vital strength. By embracing diversity in all its forms, we live out The Gallagher Way to its fullest.

Gallagher believes that all persons are entitled to equal employment opportunity and prohibits any form of discrimination by its managers, employees, vendors or customers based on race, color, religion, creed, gender (including pregnancy status), sexual orientation, gender identity (which includes transgender and other gender non-conforming individuals), gender expression, hair expression, marital status, parental status, age, national origin, ancestry, disability, medical condition, genetic information, veteran or military status, citizenship status, or any other characteristic protected (herein referred to as “protected characteristics”) by applicable federal, state, or local laws.

Equal employment opportunity will be extended in all aspects of the employer-employee relationship, including, but not limited to, recruitment, hiring, training, promotion, transfer, demotion, compensation, benefits, layoff, and termination. In addition, Gallagher will make reasonable accommodations to known physical or mental limitations of an otherwise qualified person with a disability, unless the accommodation would impose an undue hardship on the operation of our business.

Summary

The Toyoda Gosei Group is a leading global manufacturer of rubber and plastic automotive components, safety systems and LEDs. Globally Headquartered in Japan with a network of 67 group companies in 17 countries and regions, the Group brings its extensive range of products to customers all over the world.

Toyoda Gosei North America (headquartered in Troy, MI) has an opening for a Buyer in the Purchasing department. The Buyer functions with a high degree of autonomy, and is responsible for responsible for providing professional level production related procurement for Toyoda Gosei (TG) North America Corporation (TGNA) and TGNA Manufacturing Companies (AMCs).

Essential Duties and Responsibilities

• Drive cost savings initiatives such as annual price review, VA/VE, and others as assigned
• Lead Annual Price Review negotiations with existing suppliers for cost reductions
• Support VA/VE activities with suppliers and TG cross functional groups to drive cost savings
• Negotiate price increases and tariffs with suppliers
• Implement sourcing & new program launch activities with new/existing materials
• Participate in new program launch activities with manufacturing plants, cross functional departments, and suppliers
• Issue, collect, negotiate and analyze RFQ’s and cost breakdowns with new and existing suppliers
• Analyze and forecast Petrochemical/Metals market data for price negotiations and budget preparation
• Maintain purchase order data and ensure approvals for upcoming purchases
• Contribute to commodity strategy development
• Communicate with TG Japan (HQ) regarding global material strategies
• Participate in Purchasing’s annual cost saving target setting and strategy development
• Partner with TG cross functional groups and locations in new material development, commercial agreement strategies, commodity sourcing strategies, and cost reduction initiatives
• Function in a highly collaborative environment where flexibility and teamwork is critical to success
• Drive optimization by being actively engaged in continuous improvement efforts
• Manage and resolve supplier issues as needed
• Travel to TG manufacturing plants and supplier as needed
• Drive optimization by being actively engaged in continuous improvement efforts (kaizen)
• This role requires the completion of other duties as assigned

Required Education, Experience, and Skills

Certifications and Education

• Bachelor’s degree in Engineering, Supply Chain Management, Business or related field is required, or equivalent years of relevant experience is required

Experience

• 1 to 4 years of experience in Purchasing function is preferred
• Strong desire to learn all aspects of Purchasing and a willingness to expand to other commodities is preferred
• Exposure to the development of short and long-term global purchasing strategy is preferred

Physical Requirements

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision.

Technology Competencies

• Proficiency using Microsoft Office Suites is required

Work Environment

• Office Environment

Additional Competencies

• Ability to consistently meet deadlines is required
• Effective verbal, non-verbal, negotiation and written communication skills are required
• Ability to sustain a high degree of professionalism in interacting with internal and external customers is required
• Effective attention to detail, problem solving, analytical and organizational skills are required

Benefits (subject to eligibility):

• Hybrid Work Style (if eligible)
• Insurance (Health, Dental, Vision, Prescription Drug Program)
• Company Paid STD, LTD, Life, and AD&D
• Generous Employer Contribution to HSA
• Short and Long Term Disability
• 401K Company Match
• Paid Time Off/Holidays
• Free Employee Assistance Plan (EAP)
• Reimbursement Programs (Cellphone, Tuition, Vehicle, etc.)
• Multiple Free Wellness Programs Offered

About the Role

Kolon TissueGene, Inc. is seeking an Associate Director, Clinical Quality Assurance responsible for maintaining the Quality Management System and other programs to support Clinical Operations and commercialization of biopharmaceutical products. This role will ensure that all Clinical QA details are managed efficiently and exhibit continuous improvement.

Reporting to the Head of Quality Assurance, this role will support Inspection Readiness, regulatory Inspections, Quality policies and procedures. The Associate Director, Quality Assurance will work with Clinical Operations and Regulatory Affairs to ensure adherence to KTG policies, programs, and procedures in support of commercialization. A fundamental measure of success for the position will be a successful BLA Approval Inspection and launch of commercialized drug products.

This position is based on-site at our Rockville, Maryland headquarters.

Key Responsibilities

Quality Systems Leadership

• Lead the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), including Change Control, Deviations, Complaints, Vendor Management, and Audit programs.
• Ensure quality processes and systems meet FDA and global regulatory expectations.
• Oversee electronic quality systems supporting training management and GxP document control.

Clinical Quality Oversight

• Drive the GCP Quality strategy across clinical development programs.
• Provide independent Quality oversight of Clinical Operations to ensure compliance with regulatory and internal quality requirements.
• Review and approve clinical and nonclinical documentation, including protocols, amendments, deviations, CAPAs, and change controls.
• Oversee the development and maintenance of Clinical SOPs.
• Manage training qualification and compliance for Clinical Operations and Data Management teams.

Inspection Readiness & Regulatory Support

• Lead inspection readiness activities across clinical programs.
• Serve as a lead representative during FDA inspections and vendor audits.
• Support regulatory interactions including GCP inspections, Pre-Approval/BLA inspections, and investigator site inspections.
• Ensure clinical programs maintain inspection-ready documentation and processes.

Risk Management & Continuous Improvement

• Lead quality risk management initiatives, facilitating risk assessments and implementing mitigation strategies.
• Identify opportunities for process improvements and quality system enhancements.
• Ensure quality initiatives and projects are properly resourced and executed within established timelines.

Leadership & Team Development

• Build and lead a high-performing Clinical QA team.
• Manage hiring, coaching, and development of Quality staff.
• Promote a culture of quality, compliance, and “first-time-right” execution.
• Ensure team members maintain appropriate training and qualifications.

Operational & Strategic Support

• Develop and manage Quality department timelines, budgets, and resource planning.
• Provide regular updates to senior leadership and project teams regarding Clinical QA activities and inspection readiness.
• Manage Quality vendor relationships and contracts, including quality consultants and electronic quality system providers.

Qualifications

Education

• Bachelor’s degree in Biological Sciences, Life Sciences, Physical Sciences, or a related discipline required
• Advanced degree (M.S., Ph.D., or equivalent) preferred

Experience

• 10+ years of experience in the biopharmaceutical industry, with a minimum of 8 years demonstrated experience of direct interaction with FDA and other regulatory agencies through GCP, Pre-Approval/BLA Inspections, and Investigator Site inspections.
• 6+ years of leadership experience in Clinical Quality Assurance roles
• Experience developing, implementing, and maintaining Quality Management Systems (QMS)
• Experience working with Clinical Operations and Regulatory Affairs teams in regulated development environments
• Experience in cell and gene therapy programs or advanced biologics preferred

Core Competencies

• Strong knowledge of ICH guidelines, FDA regulations, and GCP compliance requirements
• Expertise in Quality Management Systems, including change control, deviations, CAPA, audits, and vendor oversight
• Ability to maintain independent Quality oversight of Clinical Operations
• Strong leadership, organizational, and team development skills
• Excellent written and verbal communication skills
• Strong problem-solving and risk management capabilities
• Demonstrated commitment to quality, compliance, and continuous improvement

Work Environment & Physical Requirements

• On-site position with up to approximately 20% travel.
• Extensive computer and keyboard use involving repetitive motion.
• Regular telephone and in-person communication.
• Ability to lift up to 25 pounds, with or without reasonable accommodation.

Kolon TissueGene will provide reasonable accommodations for qualified individuals with disabilities in accordance with the Americans with Disabilities Act (ADA) and applicable state law.

Why Join Kolon TissueGene?

Kolon TissueGene is advancing innovative regenerative cell and gene therapies designed to address the root causes of disease. As a member of our Bioinformatics team, you will contribute directly to the scientific rigor and data integrity that enable safe, effective therapies to reach patients.

About Us

Kolon TissueGene, Inc. (KTG) is a clinical-stage biopharmaceutical company developing first-in-class regenerative therapies, including TG-C for osteoarthritis of the knee. We are building a mission-driven team committed to scientific excellence, regulatory compliance, and patient impact.

Benefits Highlights:

• Onsite yet Flexible work schedules
• Premium-free global health insurance (50% dependent coverage)
• 401(k) with immediate eligibility
• Long-term incentive bonuses
• On-site gym & wellness perks
• Extra PTO accrual every year
• Global and local training opportunities
• Visa sponsorship available for qualified candidates

Equal Opportunity Employer

Kolon TissueGene, Inc. is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration without regard to race, color, religion, gender, identity, sexual orientation, national origin, disability, or veteran status.

Apply today to shape the future of regenerative medicine with precision, rigor, and purpos