Senior Quality Assurance Manager
3 days ago
The Sr. Director, GMP Quality Assurance will collaborate with internal and external parties to promote and deliver compliant Quality outcomes by working closely with CDMOs, Manufacturing, Analytical Development & Quality Control, Regulatory, Quality Management Systems, and Clinical Trial Material Management.
Responsibilities- Build and maintain Quality processes needed to support Quality oversight of Technical Operations deliverables, including but not limited to supplier management, tech transfer, production, packaging, labeling, lot disposition, change control, and deviations
- Establish, monitor metrics, reporting, and support cross-functional review forums, including the Quality Management Review process
Qualifications
- Demonstrated ability to function as both a functional leader and an individual contributor capable of defining and driving work independently
- Efficacy and efficiency in making and acting on decisions while balancing speed, quality, and risk to deliver value-added business results that meet high-quality requirements with tight deadlines
The target salary range for this full-time role is $255,000 - $300,000 + bonus + equity + benefits.
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