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Manager Gmp Quality Assurance Jobs (NOW HIRING)

DivIHN

QA Contractor, GMP Quality Assurance

NC · On-site

QA Contractor, GMP Quality Assurance Location: Onsite at Research Triangle Park, NC Duration: 9 ... Manage assigned day-to-day QA responsibilities in support of the company's Quality Management ...

Jade Biosciences

Supports management of Quality Agreements, including project coordination, cross-functional review ... GMP Quality Assurance at an operational level supporting manufacturing and quality control in a ...

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

As of Aug 9, 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 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 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 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, 80% Full Time, 14% Part Time, 4% Contract, and 1% Nights. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $118,074 per year, or $56.8 per hour.

Senior Manager, GMP QA Operations

Dyne Therapeutics

Waltham, MA

Full-time

Re-posted 3 days ago

Job description

Role Summary:

The Senior Manager, GMP QA Operations oversees quality activities associated with contract manufacturing organizations (CMOs) and ensures compliance with FDA and global GMP regulations. Leads tactical GMP QA operations supporting manufacturing, testing, deviation investigations, and CAPA implementation to enable compliant product disposition for clinical development and future commercialization. Partners cross-functionally to ensure quality systems are effectively applied and continuously improved to support Dyne Therapeutics' pipeline. 

This is an onsite role based in Waltham, MA.

Primary Responsibilities Include: 

Quality Operations Execution
  • Oversees release activities for Drug Substance (DS) and Drug Product (DP), including batch record review and disposition decisions
  • Assembles product disposition packages and Certificates of Conformance to support clinical trial supply and commercialization readiness
  • Ensures timely and compliant execution of GMP QA activities across manufacturing and testing operations
External Manufacturing Oversight (CMOs)
  • Represents GMP QA in interactions with CMOs, including governance meetings and operational discussions
  • Ensures contract manufacturing activities align with applicable regulatory requirements, industry standards, and internal expectations
  • Monitors vendor quality performance through defined metrics and ensures adherence to GMP requirements
Quality Systems & Compliance
  • Leads and supports GMP investigations, including root cause analysis, CAPA development, tracking, and effectiveness verification
  • Partners with internal teams to support change management activities impacting manufacturing and testing
  • Works within and enhances internal processes for batch record review and quality event management to ensure timely resolution of compliance issues
  • Develops and tracks Quality Operations metrics (KPIs) for Management Review
Cross-Functional Collaboration & Continuous Improvement
  • Collaborates with Manufacturing, Quality Control, Supply Chain, Regulatory Affairs, and Project Management to ensure alignment on quality objectives
  • Partners with Quality Management Systems teams to drive consistency and continuous improvement across quality processes
  • Communicates quality risks, issues, and trends clearly to stakeholders to support informed decision-making
 

Education and Skills Requirements: 

  • Bachelor's degree in Engineering, Science, or relevant discipline; or Master's Degree preferred
  • 6+ years' experience in related cGMP environment (e.g., Medical Device, Diagnostic, Pharmaceutical, or other similar regulated industry) 
  • 4+ years of related work experience in Quality Assurance or closely related role within Medical Device, Diagnostic, Pharmaceutical, or other similar regulated industry, preferably with experience overseeing CMO/CDMO organizations. 
  • Broad understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations. 
  • A proven track record of demonstrating good judgement & decision-making experience. 
  • Excellent organizational skills. 
  • Ability to concisely present quality events and the criticality to internal stakeholders. 
  • Excellent interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues. 
  • Experience with GXP QA systems, processes, and procedures such as documentation and record management, change control, deviations, investigations, training, and CAPA. 
  • A working knowledge of the therapeutic industry would be beneficial. 
  • Results oriented, establishing clear expectations and priorities, sets objectives and effectively applies resources.  
  • Flexible and creative problem-solving skills; ability to challenge current processes, practices, and strategy and uncover alternative approaches, solutions, or methods. 
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders and who is enthusiastic and willing to jump in to meet to all QA activities when required. 
  • Proficiency with software applications such as MS Office, SmartSheet, Veeva a plus 

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