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Associate Director Gmp Quality Systems Jobs (NOW HIRING)

About the Role >>> Associate Director GMP Quality As the Associate Director, GMP Quality, reporting ... Familiarity with effective Quality Systems and performing robust investigations * Experience with ...

... Associate Director, GMP Quality Assurance, will be responsible for ensuring the compliant onboarding, qualification, and validation of equipment, instruments, and computerized systems against ...

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How much do associate director gmp quality systems jobs pay per year?

As of Sep 10, 2026, the average yearly pay for associate director gmp quality systems in the United States is $125,600.00, according to ZipRecruiter salary data. Most workers in this role earn between $91,000.00 and $151,000.00 per year, depending on experience, location, and employer.

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Infographic showing various Associate Director Gmp Quality Systems job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 13% Part Time, 4% Contract, and 1% Nights. Highlights an 84% Physical, 1% Hybrid, and 15% Remote job distribution, with an average salary of $125,600 per year, or $60.4 per hour.

Associate Director, GMP Quality

Cambridge, MA โ€ข On-site

Scorpion Therapeutics
51 - 200 employees

$160K - $180K/yr

Other

Posted 12 days ago


Job description

Associate Director, GMP Quality
  • Batch disposition/release for Clinical Trial Materials and Commercial batches
  • Technical review, quality oversight, and approvals of Master Batch records and Executed Batch records
  • Review/approve CMO deviations, CAPA, and Change Controls; open internal shadow records when required
  • Technical review of Quality Control records (e.g., Certificate of Analysis, Analytical Testing, Method Validation, Stability reports)
  • Operational oversight of CMOs per quality agreements (may include periodic CMO visits)
  • Serve as Person in Plant (PIP) when critical processing occurs
  • Support Pre-Approval Inspection readiness for NDA/commercial launch
  • Review sections of New Drug Applications for content and accuracy
  • Review Quality Agreements and support supplier audits
  • Interact with Qualified Persons (QP) to facilitate release of Clinical and Commercial product
  • Generate metrics for Quality Management Reviews; contribute to Annual Product Quality Reviews
  • Represent GMP Quality during internal and regulatory inspections
  • Author Quality department SOPs as required
Qualifications / Key requirements:
  • Bachelor's degree required; MS/PharmD/PhD preferred
  • Extensive understanding of industry standards and current cGMP (21 CFR Parts 210/211), EudraLex Vol. 4, ICH Q7 and related GMP Quality Assurance guidance
  • Minimum 8 years in an FDA-regulated Pharmaceutical GMP/GMP QA role
  • Experience with small molecule synthesis and analytical test record review
  • Prior NDA/BLA submission and commercial launch experience
  • Familiarity with Quality Systems and robust investigations; Health Authority filings and EU QP queries
  • Experience managing CMO relationships and supporting CMO inspections
  • Experience with Quality Management Systems (e.g., Veeva or TrackWise)
  • Proficient in Word, Excel, PowerPoint, SharePoint
Skills/attributes:
  • Leadership, communication, adaptability, collaboration
  • Clear writing and verbal presentation; ability to prioritize and work independently

Travel: 10-15% (some international)

Compensation/benefits:
  • Base pay range: $160,000-$180,000 annually; total compensation includes equity, bonus, and benefits. A Summary of Benefits is available for applicants.
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