Director, GMP Quality Assurance
New
J
Jade BiosciencesBiotechnology
This is a fully remote role, preferably based on the U.S. West CoastFull-TimeDirector
Salary210,000 - 235,000 USD per year
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Job Details
- Experience
- Bachelor’s degree and 15 years of experience or a master’s degree with 12+ years of experience in scientific discipline or comparable experience; 10+ years of experience in GMP Quality Assurance
- Required Skills
- Quality AssuranceRisk Management
Requirements
- Bachelor’s degree with 15+ years of experience or Master’s degree with 12+ years of experience in a scientific discipline.
- 10+ years of experience in GMP Quality Assurance in a pharmaceutical or biotech environment.
- In-depth knowledge of GMP, FDA, EMA, and ICH regulations.
- Experience managing CDMOs, technology transfer, scale-up, and validation.
- Experience supporting regulatory authority inspections and submissions (e.g., IND, BLA).
- Strong communication and influencing skills with a risk-based approach to decision making.
- Proficiency with MS Office, Visio, Adobe Acrobat, and SharePoint.
Responsibilities
- Serve as the QA lead for assigned GMP-related activities including quality oversight of CDMOs, tech transfer, scale-up, and manufacturing.
- Quality reviewer and approver for quality records such as change controls, CAPAs, deviations, temperature excursions, and product complaints.
- Collaborate with CMC, Supply Chain, and Analytical Development to ensure compliance and on-time delivery.
- Manage Quality Agreements and provide proactive quality guidance in product development teams.
- Lead quality risk management activities to identify and mitigate GMP-related risks.
- Facilitate resolution of quality issues and coordinate communications with internal and external parties.
- Review CMC sections of regulatory filings and support regulatory authority inspections.
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