Director, GMP Quality Assurance
New
J
Jade BiosciencesBiotechnology
United StatesFull-TimeDirector
Salary210,000 - 235,000 USD per year
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Job Details
- Experience
- 15 years (Bachelor's degree) or 12+ years (Master's degree) in scientific discipline
- Required Skills
- Quality AssuranceRisk Management
Requirements
- Bachelor’s degree and 15 years of experience or a master’s degree with 12+ years of experience in a scientific discipline.
- 10+ years of experience in GMP Quality Assurance at an operational level within a pharmaceutical or biotech environment.
- In-depth knowledge of GMP, FDA, and EMA regulations, as well as ICH guidelines.
- Experience managing CDMOs and technology transfer, scale-up, and validation processes.
- Experience supporting regulatory authority inspections and submissions, such as INDs and BLAs.
- Strong ability to research and interpret international GMP regulations.
- Excellent verbal, written, interpersonal, and organizational skills.
- Proficiency with MS Office, Visio, Adobe Acrobat Professional, and SharePoint.
- Ability to thrive in a fast-paced environment and manage competing priorities.
Responsibilities
- Serve as the QA lead for assigned GMP-related activities including quality oversight of CDMOs, tech transfer, scale-up, and manufacturing.
- Review and approve quality records such as change controls, CAPAs, deviations, temperature excursions, and product complaints.
- Collaborate with CMC, Supply Chain, and Analytical Development teams to ensure product compliance and timely delivery.
- Represent the Quality function in product development teams to provide proactive quality guidance.
- Lead quality risk management activities to identify and mitigate GMP-related risks.
- Support regulatory authority inspections, internal audits, and the review of CMC sections for regulatory filings.
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