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Gmp Quality Analyst Jobs (NOW HIRING)

Associate Director, GMP Quality

Boston, MA ยท On-site

$160K - $180K/yr

There will be associated responsibilities for reviewing Analytical Development / Quality Control results. In this position you will perform GMP activities such as, but not limited to, review of ...

QA Contractor, GMP Quality Assurance Location: Onsite at Research Triangle Park, NC Duration: 9 ... Experience in analytical method validation and QC testing, especially in the fields of mammalian ...

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Gmp Quality Analyst information

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How much do gmp quality analyst jobs pay per hour?

As of Sep 10, 2026, the average hourly pay for gmp quality analyst in the United States is $32.41, according to ZipRecruiter salary data. Most workers in this role earn between $24.28 and $37.02 per hour, depending on experience, location, and employer.

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For Gmp Quality Analyst jobs, the most frequently searched job titles are:

Associate Director, GMP Quality

Cambridge, MA โ€ข On-site

Scorpion Therapeutics
51 - 200 employees

$160K - $180K/yr

Other

Posted 11 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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