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Manager Gmp Quality Assurance Jobs (NOW HIRING)

Ionis

Executive Director, GMP Quality

Carlsbad, CA · On-site

... managed through CMOs and other service providers. The position is accountable for ensuring effective GMP Quality oversight and for developing and enhancing QA operations in accordance with applicable ...

Formation Bio

Associate Director, GMP Quality

Boston, NY · On-site

$161K - $202K/yr

About the Position The Associate Director, GMP Quality Assurance is responsible for ensuring that ... Apply risk management principles (e.g., FMEA) to guide decision-making * Champion a culture of ...

Dyne Therapeutics

Director, QA GMP Operations

Waltham, MA · On-site

$188K - $230K/yr

The Director of QA GMP Operations is responsible for management of GMP quality within our external manufacturing operations globally and internal GMP operations for development and commercial ...

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How much do manager gmp quality assurance jobs pay per year?

As of Sep 6, 2026, the average yearly pay for manager gmp quality assurance in the United States is $118,074.00, according to ZipRecruiter salary data. Most workers in this role earn between $83,000.00 and $144,500.00 per year, depending on experience, location, and employer.

What are the responsibilities of a Manager GMP Quality Assurance?

A Manager GMP (Good Manufacturing Practice) Quality Assurance oversees compliance with regulatory and company quality standards for pharmaceutical or biotech manufacturing. They develop, implement, and monitor quality management systems, manage audits and inspections, and ensure that all processes align with GMP guidelines. This role often involves training staff, investigating quality issues, and working closely with other departments to maintain product safety and integrity.

What are the key skills and qualifications needed to thrive as a Manager GMP Quality Assurance?

To thrive as a Manager GMP Quality Assurance, you need a strong understanding of Good Manufacturing Practices (GMP), quality systems, and regulatory compliance, typically supported by a degree in life sciences or a related field. Familiarity with quality management systems (QMS), audit processes, and industry-specific standards such as FDA or EMA regulations is crucial, and certifications like ASQ Certified Quality Auditor can be beneficial. Leadership, attention to detail, and effective communication are valuable soft skills for managing teams and ensuring compliance. These competencies are essential for maintaining product quality, regulatory adherence, and the reputation of the organization.

What are some common challenges faced by a Manager GMP Quality Assurance, and how can they be addressed?

A Manager GMP Quality Assurance often faces challenges such as staying up-to-date with evolving regulatory requirements, managing cross-functional teams, and ensuring consistent compliance across all processes. Balancing the demands of production schedules with the need for thorough documentation and quality checks can also be demanding. To address these challenges, it is essential to foster a culture of open communication, provide regular training for staff, and implement robust internal audit systems to identify and correct issues proactively.

What is the difference between Manager Gmp Quality Assurance vs Quality Assurance Specialist?

AspectManager Gmp Quality AssuranceQuality Assurance Specialist
CertificationsGMP certifications, QA certificationsGMP certifications, QA certifications
Work EnvironmentOversees QA teams in pharmaceutical/biotech companiesSupports QA activities under supervision in similar settings
ResponsibilitiesDevelops QA strategies, manages teams, ensures GMP compliancePerforms QA testing, audits, and documentation tasks

The main difference is that the Manager Gmp Quality Assurance holds a leadership role, overseeing QA teams and strategic compliance, while the Quality Assurance Specialist focuses on executing QA tasks and supporting the QA process. Both roles require GMP knowledge and certifications, but the manager has broader responsibilities and leadership duties.

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Manager Gmp Quality Assurance jobs near you
Infographic showing various Manager Gmp Quality Assurance job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 14% Part Time, 3% Contract, and 1% Nights. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $118,074 per year, or $56.8 per hour.

Coordinator-TCT/GMP Quality Assurance

Loma Linda University Health

Loma Linda, CA

Full-time

Re-posted 16 days ago

Loma Linda University Health rating

8.2

Company rating: 8.2 out of 10

Based on 88 frontline employees who took The Breakroom Quiz

100th of 1,065 rated hospitals

Job description

Job Summary: The Coordinator-TCT/GMP Quality Assurance oversees quality assurance and regulatory compliance activities for LLUH TCT/GMP Laboratory, ensuring adherence to FDA, FACT, IRB, and other applicable standards. This role manages the Quality Management System (QMS), including SOPs, audits, CAPA programs, inspection readiness, regulatory submissions, staff training, and accreditation support. The coordinator collaborates with laboratory leadership, investigators, and institutional stakeholders to support compliant cellular therapy manufacturing operations, while also leading process improvement initiatives, monitoring supplier and material quality, preparing compliance reports, and providing operational support for TCT/GMP production and quality control activities as qualified. Performs other duties as needed.

Education and Experience: Bachelor's degree in Life Sciences or an equivalent field of study required. Master's degree preferred. Five years of experience as a Quality Specialist or Coordinator, within regulated clinical, blood or tissue banking or manufacturing environment preferred.

Knowledge and Skills: In-depth knowledge of laboratory safety standards, GxP compliance, and Quality Management Systems (QMS) in a regulated laboratory environment. Comprehensive knowledge of laboratory operations and understanding of cell therapy manufacturing, processing, quality control testing, and product release. Familiarity with regulatory and accreditation standards, including FDA, FACT, IRB, IND/IDE, and other applicable federal and institutional requirements. Able to speak, read and write legibly in English with professional quality; use computer and software programs necessary to the position (e.g., Microsoft Office, document control, quality management and laboratory information management systems, if applicable). Able to demonstrate excellent planning and organization skills; analyze and interpret complex information; prioritize work and resources; define problems and solutions; make recommendations; manage time effectively. Able to relate and communicate positively, effectively, and professionally with others; be assertive and consistent in following and/or enforcing policies; work calmly and respond courteously when under pressure; collaborate; accept direction; think critically; work independently with minimal supervision; perform basic math functions and statistical functions; manage multiple assignments effectively; problem solve; recall information with accuracy; pay close attention to detail. Able to distinguish colors as necessary; hear sufficiently; see adequately to read computer screens, and written documents necessary to the position.

Licensures and Certifications: California Clinical Laboratory Scientist License preferred.

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About Loma Linda University Health

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Loma Linda University Health (LLUH) is an esteemed healthcare organization situated in Loma Linda, California, US. Established in 1905, it was initially known as the College of Medical Evangelists, and it operated as the official medical institution of the Seventh-day Adventist Church until the name was changed to LLUH in 1961. LLUH is very much active in the healthcare and education sectors, providing a vast range of services such as medical treatment, research, and health education. The organization’s core mission is "to continue the teaching and healing ministry of Jesus Christ", which underlines its binding values of compassion, integrity, excellence, freedom, and justice.

Industry

Health care and social assistance and hospitality services

Company size

10,000+ Employees

Headquarters location

Loma Linda, CA, US

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