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Director, GMP Quality Assurance

1 month, 2 weeks ago
United States
Full-time
Lead
Manual QA Tester
Quality Assurance and Testing
Apply Now
Jade Biosciences

Jade Biosciences

Jade Biosciences is focused on developing innovative therapies aimed at redefining the standard of care for patients with autoimmune diseases, with a clinical pipeline that includes its lead candidate, JADE101, which is designed to inhibit the cytokine...

Pharmaceuticals
Founded 2024
View All Jobs 3

Description

  • Serve as the QA lead for GMP activities across tech transfer, scale-up, manufacturing, and disposition of clinical materials.
  • Provide quality oversight of CDMOs, internal teams, and service providers supporting cell bank, drug substance, drug product, finished drug product packaging and labeling, and product distribution.
  • Review and approve quality records including change controls, CAPAs, deviations, temperature excursions, product complaints, expiry/retest actions, stability documents, master batch records, and method qualifications.
  • Collaborate with CMC, Supply Chain, Analytical Development, Program Management, Regulatory, Clinical Supply Chain, and Program Leadership to support compliant development and supply operations.
  • Maintain and archive quality records, tracking logs, and quality metrics, and support timely documentation and batch release decisions.
  • Manage quality agreements, including project coordination, cross-functional review, and approval workflows.
  • Lead quality risk management activities to identify, assess, and mitigate GMP-related risks.
  • Resolve quality issues and coordinate communications with CMOs and internal technical teams.
  • Review CMC sections of regulatory filings and support regulatory inspections and internal audits.
  • Support development and maintenance of Quality SOPs and promote cross-program alignment and consistency in QA practices.

Requirements

  • Bachelor’s degree with 15 years of experience, or a master’s degree with 12+ years of experience, in a scientific discipline or comparable experience.
  • 10+ years of operational GMP Quality Assurance experience supporting manufacturing and quality control in a pharmaceutical or biotech environment.
  • Experience across all phases of development, including Phase 1-4 and commercial.
  • In-depth knowledge of FDA, EMA, device and combination product GMP guidelines, and other ICH guidelines.
  • Ability to research and interpret international GMP regulations and guidance.
  • Experience managing CDMOs.
  • Experience with technology transfer, scale-up, and validation.
  • Experience supporting regulatory authority or notified body inspections.
  • Experience supporting regulatory submissions such as INDs and BLAs, and responding to FDA or EMA queries.
  • Excellent verbal, written, interpersonal, organizational, communication, influencing, and problem-solving skills; proficiency with MS Word, Excel, Visio, Adobe Acrobat Professional, and familiarity with SharePoint.

Benefits

  • Remote role with preference for U.S. West Coast candidates.
  • Up to 15% travel to team and company events.
  • Anticipated salary range of $210,000 to $235,000.
  • Equal opportunity employment and consideration for all qualified applicants.
  • Participation in E-Verify for U.S. work authorization verification.

Interested in this position?

Apply directly on the company website

Apply Now

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