Jobs in Bloomfield Hills, MI
485 positions found — Page 21
LitFinancial is on a mission to be the most client focused mortgage company in the industry. As of 2025, LitFinancial has earned a perfect 5-star review with the Better Business Bureau and a 4.9 rating with hundreds of reviews from Google by delivering a world class experience. LitFinancial is a dynamic organization built with go-getters who are passionate, hardworking, and honest which fuels an incredible environment.
Position Overview:
As a Senior Loan Processor, you will manage a high-volume loan pipeline from submission through clear to close with minimal supervision. You will act as a subject matter expert and resource to junior processors, ensuring accuracy, compliance, and client satisfaction. This role requires deep knowledge of mortgage guidelines and strong communication with internal and external partners.
Key Responsibilities:
- Independently process and manage a pipeline of complex Conventional, FHA, and VA loans.
- Manage a high-volume, purchase-focused pipeline while consistently closing 20–25 loans per month.
- Analyze and verify all loan documentation for accuracy and compliance.
- Review and satisfy underwriting conditions and communicate requirements clearly to clients.
- Coordinate effectively with loan officers, underwriters, and closers to ensure timely closings.
- Maintain compliance with TRID, RESPA, and company guidelines.
- Mentor and support junior processors, providing guidance and training as needed.
- Identify process improvements and contribute to team efficiency initiatives.
Qualifications
- 3+ years of mortgage loan processing experience (Conventional preferred; FHA/VA a plus).
- Deep understanding of mortgage lending regulations, TRID, DU/LP, and investor requirements.
- Advanced proficiency in LOS systems (LendingPad, Encompass, or equivalent).
- Exceptional organizational and communication skills with the ability to prioritize under pressure.
- Preferably strong purchase-loan experience with tight contract and closing timelines.
- Proven ability to handle complex loan files (self-employed borrowers, appraisal or title challenges).
- High school diploma or equivalent (college degree preferred).
What We Offer
Competitive salary: base + performance-based bonuses
Comprehensive Benefits: Medical, dental, vision, and life insurance
Paid Time Off: PTO + 7 paid holidays
401(k) Plan: Retirement plan through Principal
Career growth opportunities and a collaborative team environment!
Job Title: Desktop Support Manager
Skills: Pix boot, SCCM/ Intune, Active Directory 360 issues, BitLocker, MFA & Google DUO, autopilot, People management
Experience: 15+ Years
Location: Southfield, Michigan, United States
Job Type: Fulltime
We at Coforge are hiring for Desktop Support Manager with the following skills:
- Deskside Support Associate – Experienced Deskside Support professional with 15+ years of hands-on experience providing end-user support for laptops and desktops, including imaging, hardware/software troubleshooting, printer issue resolution, shipping, field services, and receiving IT equipment.
- Strong expertise in device imaging using PXE Boot, SCCM, and Intune, along with resolving Active Directory (Azure AD / AD 360) related issues. Proficient in security and access management tools including BitLocker, MFA, and Google Duo.
- Proven Team Lead and People Management experience, including mentoring junior technicians, assigning tasks, monitoring SLAs, and acting as an escalation point for complex technical issues. Demonstrated ability to coordinate with cross‑functional teams, manage on‑site support operations, and ensure high levels of customer satisfaction while meeting business and compliance requirements.
- Experience with autopilot.
- Experience in resolving Level 1 / Level 2 password, access & general laptop issues.
- Must have experience in supporting hybrid/Remote users in a large enterprise environment.
- Graduation or equivalent degree is mandatory.
Responsibilities:
- Test and troubleshoot automation equipment and electronic control systems
- Debug machine controls and adjust machine parameters as needed
- Run software and system tests to verify functionality and performance
- Analyze test data and help identify system or programming issues
- Work with engineering teams to resolve hardware and software problems
- Assist with PLC ladder logic debugging and basic CNC programming
- Support machine tryouts, final testing, and equipment runoffs
- Help with equipment startup and installations at customer sites when needed
Qualifications:
- Experience troubleshooting industrial automation or machine controls
- Familiarity with PLC ladder logic and automation systems
- Exposure to CNC machines, metal cutting machines, or assembly equipment
- Ability to read technical documentation and work with engineering teams
- Comfortable traveling occasionally for machine installations or startups
Nice to Have:
- Experience supporting machine builds, tryouts, or commissioning
- Background in controls engineering, automation, or electrical troubleshooting
Are you an RN looking for a leadership role? Do you have a passion for leading and teaching other skilled nursing staff? The RN Unit Manager provides, plans, coordinates or manages nursing care and health education for nursing home guests.
At Ciena Healthcare, we take care of you too, with an attractive benefit package including:
Competitive pay
Life Insurance
401K with matching funds
Health insurance
AFLAC
Employee discounts
You will join an experienced, hard-working team that values communication and strong teamwork abilities.
Responsibilities
Supervises nursing care provided by Registered Nurses (RN), Licensed Practical Nurses (LPN), Certified Nursing Assistants (CNA) and others.
Reviews and implements all nursing procedures and systems.
Assesses and evaluates the systems which facilitate the delivery of quality guest care and performance of staff.
Uses a systematic approach in the nursing process to provide individualized nursing care.
Contributes to the guest assessments (MDS/CAA’s) and the development and implementation of a plan of care.
Evaluates guests’ responses to nursing interventions.
Understands the rational for the use of medications and treatments and correctly administers as needed.
Qualifications
Current state Registered Nurse (RN) license required
Current CPR certification and additional certification in a nursing specialty desired
Management or supervisor experience in long-term care or geriatric nursing preferred
About Ciena Healthcare
Ciena Healthcare is Michigan’s largest provider of skilled nursing and rehabilitation care services.
We serve our residents with compassion, concern, and excellence, believing that every one of them is a unique person who deserves our best each day that we care for them. If you have a passion for improving the lives of those around you and working with others who feel the same way, Ciena is the place for you!
IND123
Location: Oak Park, Illinois
Business Unit: Rush Oak Park
Hospital: Rush Oak Park Hospital
Department: Respiratory Therapy
Work Type: Full Time (Total FTE 0. 9)
Shift: Shift 2
Work Schedule: 12 Hr (6:30:00 PM - 7:00:00 AM)
Rush offers exceptional rewards and benefits learn more at our Rush benefits page ( /rush-careers/employee-benefits).
Pay Range: $34.89 - $56.78 per hour
Rush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush’s anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case.
Summary:
Provides simple, intermediate, and complex therapeutic and diagnostic procedures on the general care floors and special care units. Improves and maintains patient cardiopulmonary status through the application and administration of various medications, gases, devices, and procedures. They function independently in assigned areas. Exemplifies the Rush mission, vision and values and acts in accordance with Rush Oak Park Hospital policies and procedures.
Other information:
Required Job Qualifications:
• Registered Respiratory Therapist (RRT) and an Illinois Respiratory Care Practitioner license.
• All RTs must pass departmental competencies
• Requires BLS and ACLS. PALS within 90 days of hire. NRP Preferred
• Minimum education requirement is an Associate’s degree; Bachelor’s degree preferred
• Technical skills are required to adapt equipment and procedures to patient needs.
• Analytical skills are required to evaluate patients and their clinical response to therapy.
• Customer service skills are required to effectively meet the needs of patients, families, and members of the healthcare team on an almost constant basis.
Preferred Job Qualifications:
• NRP
• Bachelor's Degree
Physical Demands:
• Standing, walking, pushing, and bending for 75% of the day.
• Ability to lift 20 pounds in order to handle cylinders
• A high level of patience must be exhibited as people learn at different speeds.
• Ability to be highly adaptable to respond to changing workloads and priorities.
Disclaimer:
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.
Responsibilities:
1. Administers, monitors, and weans mechanical ventilation; makes ventilator recommendations based on clinical assessment, technical assessment, and laboratory values; manages airways.
2. Administers bronchial hygiene and treatment procedures including aerosol therapies, chest physical therapy, and therapeutic gas administration; analyzes gases where applicable; procures and delivers gases using central piping systems and gas cylinders.
3. Assesses patients clinically before and after the administration or application of any medication, procedure or device; recommends appropriate therapy including initial therapy, changes in therapy, and discontinuance of therapy.
4. Applies CPAP and BIPAP and makes recommendations based on patient compliance, response, and laboratory values.
5. Participates in CQI and QA initiatives including work audits, abstracts, research, Daily Management System (DMS) projects, committee participation, or other activities to improve the clinical and work environments.
6. Develops patient driven protocols in conjunction with department leadership. Documents work timely, completely, and accurately, including documentation in the patient medical record, documentation in the department records, and patient billing.
7. Assesses patient oxygenation, ventilation, and hemodynamic status through clinical observation, patient assessment, physiologic monitoring including oximetry, capnography, ventilator waveform analysis, and cardiac output, ECG, and laboratory values; provides respiratory care interventions within the scope of the Rapid Response Team, performs CPR.
8. Performs bedside spirometry including spontaneous breathing parameters, PEFR, and other limited pulmonary function; identifies normal values for patients.
9. Provides patient/family education.
10. Performs ECGs and arterial puncture.
11. Participates in on-going maintenance of the blood gas equipment, QC, calibration and proficiency testing.
12. Performs bronchoscopy assist.
13. Provides clinical supervision of respiratory care students on rotation.
14. Demonstrate initiative in optimizing patient care by participating in physician rounds and documenting assessment findings and therapy changes
15. Demonstrate professionalism by belonging to the AARC/ISRC and/or pursuing education to advance ones skills
16. Other duties as assigned.
Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Location: Oak Park, Illinois
Business Unit: Rush Oak Park
Hospital: Rush Oak Park Hospital
Department: Pharmacy
Work Type: Part Time (Total FTE between 0. 5 and 0. 89)
Shift: Shift 4
Work Schedule: 8 Hr (4:00:00 AM - 11:30:00 AM)
Rush offers exceptional rewards and benefits learn more at our Rush benefits page ( ).
Pay Range: $16.48 - $23.28 per hour
Rush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush’s anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case.
Summary:
Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures. The Pharmacy Technician 1 assists pharmacists in the practice of pharmacy performing duties such as preparing, filling and labeling medications for patients in the Hospital. As patient care assignments dictate, the Technician 1 is responsive to the explicit need of all patients. When relevant, appropriate standards of practice and sensitivity to the psychosocial needs of these patient populations.
Other information:
Required Job Qualifications:
•Must be a high school graduate or equivalent
•Must have applied for State of Illinois Pharmacy Technician license
•Individual must be willing to have completed PTCB (Pharmacy Technician Certification Board) and or EXCPT certification before the next license renewal cycle (State of Illinois requirements)
Preferred Job Qualifications:
•Admitted to a guild program
•1 year hospital experience
•1 year retail pharmacy experience
•Currently a pharmacy student
•Graduated from an approved Pharmacy Tech Program
•ACPE IV certification
•Hazardous drug compounding certification
Physical Demands:
•Ability to lift/move 30-50 pounds
•Ability to stand for long periods of time (4+ hours) between breaks
•Ability to crouch when filling dispensing cabinets and bend or stand on a stool as necessary.
•May be exposed to certain hazardous materials, including but not limited to chemotherapeutic agents.
Competencies:
•Must be able to interpret and understand medical abbreviations.
•Ability to utilize technology in the pharmacy including, but not limited to Office products, Carousels, DoseEdge, WASP, MILT,MPI Pre-packer/labeling system, CII Safe, and RxVerify as needed for assigned duties.
•Recognizes the regulations for repackaging medications for non-sterile compounding and packaging.
•Analyze problems and interpret analytical data.
•Strong oral and written communication skills with an emphasis on customer service skills.
•Ability to perform work accurately with attention to detail within specified time periods.
•Ability to work cooperatively.
•Ability to handle frequent interruptions and adapt to changes in workload and work schedule.
•Ability to set priorities and solve problems.
•Ability to respond quickly to emergency requests.
Responsibilities:
A.Recognizes and identifies various classifications of medications, medication names, dosage forms and routes of administration.
B.Understand the pharmacy workflow for first doses, automated dispensing cabinet refills, cart fill and batches.
C.Understand the pharmacy workflow for medication returns and medication disposal.
D.Responsible for the accurate interpretation of EPIC pharmacy labels:
E.Responsible for the accurate and timely filling and delivery of patient-specific medications and Automated Dispensing Cabinet (ADC) restocks.
F.Responsible for the preparation of sterile and non-sterile compounding and packaging:
G.Responsible for answering phones, assisting caller with requests and any other technical duties as assigned.
H.Responsible for utilization of Epic for technical requests (i.e.: missing medications, ADCs out of stock, and responding to in-basket messages)
I.Responsible for inventory, storage and supply maintenance of assigned areas.
J.Responsible for exchanging emergency carts and completion of required documentation.
K.Responsible for knowing the laws and regulations related to controlled substances.
L.Maintain cleanliness of all equipment and work areas.
M.Responsible for learning departmental quality assurance processes and hospital safety practices.
N.Actively participates in various departmental committees and educational activities as assigned.
O.Any and all other duties as assigned.
Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
USBP is hiring immediately to fill full-time, entry-level, career positions in federal law enforcement where your prior experience in public safety, security, military police or law enforcement may qualify.
Border Patrol Agents are eligible to select from an array of federal employment benefits that include health, dental and other insurance plans, a generous annual and sick leave program, and participation in the Thrift Savings Plan, a retirement plan akin to a traditional ROTH 401(k) offering.
*Recruitment Incentive
* Newly appointed Border Patrol Agents (as defined in 5 CFR 575.102 ) will be eligible for up to $20,000 in incentives.
The first $10,000 will be paid upon successful completion of the Border Patrol Academy, with the remaining $10,000 awarded for accepting a prioritized location such as Sierra Blanca, Presidio, Sanderson, Comstock, Freer or Hebbronville, TX; Retention Incentive
* Newly appointed Border Patrol Agents may also qualify for up to $40,000 in additional incentives distributed over their first four years.
Border Patrol determines duty assignments at the time of offer based on operational needs, which may or may not align with candidates' first-choice preferences.
Relocation may be required.
Big Bend Sector Stations
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*Presidio, Van Horn,
*Sanderson, Alpine,
*Sierra Blanca, Marfa Buffalo Sector Stations
- Wellesley Island Del Rio Sector Stations
- Del Rio, Brackettville,
*Comstock, Eagle Pass North, Eagle Pass South, Carrizo Springs, Uvalde El Paso Sector Stations
- Alamogordo, Clint, Deming, El Paso, Fort Hancock, Las Cruces,
*Lordsburg, Santa Teresa, Ysleta El Centro Sector Stations
- El Centro, Indio, Calexico Grand Forks Sector Stations
- Pembina Havre Sector Stations
- Havre, Malta, Plentywood, Scobey, Sweetgrass Houlton Sector Stations
- Calais, Fort Fairfield, Jackman, Rangeley, Van Buren Laredo Sector Stations
- Laredo South, Cotulla,
*Hebbronville, Laredo West,
*Freer, Laredo North, Zapata Rio Grande Valley Sector Stations
- Rio Grande City, Fort Brown, McAllen, Brownsville, Falfurrias, Weslaco, Kingsville, Harlingen San Diego Sector Stations
- Boulevard, Brownfield, Campo, Chula Vista, Imperial Beach, Murrieta, San Clemente Spokane Sector Stations
- Colville, Curlew, Metaline Falls, Oroville Swanton Sector Stations
- Beecher Falls, Burke, Champlain, Newport, Richford Tucson Sector Stations
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*Ajo, Tucson, Nogales, Douglas, Brian A Terry, Sonoita, Casa Grande, Three Points Substation, Willcox Yuma Sector Stations
- Blythe, Yuma, Wellton Duties and Responsibilities As a BPA, you will be part of our 60,000 workforce that strives to protect the American people by safeguarding our borders, deterring illicit activity, and enhancing the nation's economic prosperity.
Detecting and questioning people suspected of violating immigration and custom laws and inspecting documents and possessions to determine citizenship or violations Preventing and apprehending undocumented noncitizens and smugglers of noncitizens at or near the borders by maintaining surveillance from covert positions to include using infrared scopes during night operations Interpreting and following tracks, marks, and other physical evidence of illegal entry of persons or contraband Performing farm checks, building checks, traffic checks, city patrols, and transportation checks Patrolling the international boundary and coastal waterways using a variety of government assets such as vehicles, horses, vessels, watercraft, off-road vehicles, ATVs, snowmobiles, and motorcycles for the accomplishment of the USBP Mission.
Qualifications You qualify for the GL-5 grade level if you possess one of the following: Experience: One (1) year of general work experience that demonstrates the ability to take charge, make sound decisions, and maintain composure in stressful situations; to learn regulations, methods, and techniques through classroom training and/or on-the-job instruction; and the ability to gather concise information through questioning, observation, and examination of documents and records; A bachelor's degree or successful completion of a full four-year course of study in any field leading to a bachelor's degree from an accredited college or university; A combination of general work experience AND successfully completed college education.
This will be calculated using your resume and official or unofficial transcripts submitted with your application.
You qualify for the GL-7 grade level if you possess one of the following: Experience: One year of specialized work experience that shows you have the skills necessary to: Make sound judgments and decisions in the use of firearms.
Analyze information rapidly and make prompt decisions where you will be expected to make arrests after the completion of required training and apply these skills in a law enforcement capacity such as criminal code enforcement, determining violations of laws, correctional or rehabilitation work involving criminal offenders, security, military, etc.
Make arrests and exercise sound judgment in the use of firearms; or develop and maintain contact with a network of informants.
A bachelor's degree with superior academic achievement, which is based on (1) class standing, (2) grade-point average (i.e., Or will receive a bachelor's degree with Superior Academic Achievement.
Or one full year of graduate-level education in a field of study related to law enforcement (e.g., criminal justice, homeland security, justice studies, law enforcement, courts and judicial systems, forensic technology, forensic psychology, or corrections and rehabilitation) from an accredited college or university; OR A Combination of Experience and Education: This will be calculated using your resume and official or unofficial transcripts submitted with your application.
Citizen to apply for this position.
S.
residency (includes protectorates as declared under international law) for at least three of the last five years.
In accordance with Public Law 100-238, this position is covered under law enforcement retirement provisions.
Candidates must be referred for selection to the Border Patrol Agent position before reaching their 40th birthday in accordance with Department of Homeland Security Directive 251-03.
The age restriction may not apply if you are currently serving or have previously served in a federal civilian law enforcement (non-military) position covered by Title 5 U.Veterans' Preference : You may also be eligible for an excepted service Veterans Recruitment Appointment (VRA).
The age restriction does not apply if you are Veterans' Preference eligible.
Formal Training : Border Patrol Academy in Artesia, New Mexico, for approximately six (6) months of intensive instruction in immigration and nationality laws, law enforcement and USBP-specific operations, driver training, physical techniques, firearms, and other courses.
Border Patrol work requires the ability to speak and read Spanish, as well as English.
Border Patrol Agents will be provided training to become proficient with the Spanish language at the Academy.
Click the Apply button on this site.
You will be linked to the CBP Talent Network registration page.
For Position of Interest, select Border Patrol Agent, then complete the pre-screening questions.
You'll then receive a link(s) to the BPA Job Opening Announcements (JOAs) on USAJOBS, the federal government's official employment site, to complete your application.
Be certain to review ALL details of the job opportunity announcement and follow all instructions in the application process, including items (resume, transcripts, etc.) You will be evaluated based on your resume, supporting documents, and the BPA Entrance Exam .
If you have questions about the application process, contact a recruiter through the U.Border Patrol page: /s/usbp .
As a subscriber to the CBP Talent Network, you'll receive monthly emails with information about webinars, career expos, and future opportunities with CBP.
We are looking for a full-time Store Help Desk Support Specialist to join the Store Support Team.
You will be an ideal candidate if you are confident in your ability to learn new tasks quickly and pay close attention to detail. You understand how to operate the POS registers. You lead by example and represent yourself positively and professionally. You can execute tasks successfully with minimal supervision, and you are friendly, outgoing, and communicate well with associates and customers.
Have flexible work schedules to cover our normal office hours, as well as the extended hours during November and December. This position will also be involved in the after-hours emergency line rotation.
POSITION RESPONSIBILITIES:
- Responds to telephone calls, emails, and other requests for support.
- Process shipping of POS equipment to stores.
- Coordinate problem resolution across internal departments.
- Basic knowledge of commonly used concepts, practices, and procedures within store operations.
- Relies on pre-established instructions and guidelines to perform the functions of the job.
KNOWLEDGE AND SKILLS PREFERRED:
- Minimum 1-2 years of retail store experience
- Excellent verbal communication skills
- Ability to think on your feet and solve problems quickly
- Organized and self-motivated
- Computer skills to easily navigate software products to reset passwords, MS Office, call tracking, and email.
BENEFITS
- Health, dental, and prescription coverage
- Life, STD, LTD Insurance
- Vacation and PTO days
- 401 (k) Savings plan
- Merchandise Discount
Do you want to become a surrogate? We are now offering a sign on bonus to all qualified and matched surrogates that sign contracts. The first step is to fill out our surrogate application. A fertility specialist will contact you to continue the process. For intended parents interested in surrogacy to start or grow their families please contact us today. The surrogacy process is complex, but we will be with you every step of the way. Call today to get started.
Women who may have the ability to produce eggs but are unable to use their uterus or do not have a uterus, may consider a surrogate. A donated egg may also be used with the surrogate in the event a woman cannot produce her own eggs or her uterus is not intact or insufficient to carry a pregnancy. In either case, the husband's sperm, if viable, may be used.
Using an egg donor unrelated to the surrogate carrier eliminates any biological tie. The egg of the surrogate is never used as part of the assisted reproduction process, so that a surrogate is never in the position of delivering her own biological child.
The basic requirements of a woman to serve as a surrogate are:
- Emotionally stable
- Responsible
- In good physical health
- Non-smoker
- Has had at least one successful pregnancy
- Is capable of carrying a child to full term
A woman is not required to fall within a particular age range to serve as a surrogate, but most intended parents prefer a surrogate under the age of 40. For more information on surrogacy please see the documents on the left side of this page.
In Texas, there is a judicial process for validating the Gestational Contract (the contract between the intended parents and the surrogate). Included within the various requirements for having a Gestational Contract validated by a Texas court is that the intended parents must be married and the surrogate must have previously carried a child to term. Additionally, there are residency requirements that apply to either the surrogate or the intended parents, but not both.
Compensation for a surrogate services generally starts in the range of $35,000 - $40,000, for base compensation with over all fees up to 70k, in many cases. The amount of compensation is dependent upon a variety of factors, including, but not limited to, whether the surrogate carries twins, what procedures a surrogate is required to undergo and whether the delivery is vaginally or by cesarean section.
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
