Senior Director, Quality
ORIC Pharmaceuticals Inc. · San Diego
Job description
About the role
ORIC Pharmaceuticals is seeking a Senior Director of Quality to provide strategic oversight of quality across its clinical development and manufacturing programs. Reporting to the Senior Vice President of Quality, you will lead the CMC QA team and shape quality systems that support both clinical and commercial product lifecycles.
Key responsibilities
- Ensure compliance with all applicable local and global drug regulations.
- Oversee Quality CMC functions, including batch disposition, manufacturing, packaging, labeling, and testing.
- Provide hands‑on leadership for investigations, process and analytical data review, supply distribution, and risk management.
- Serve as the primary point of contact for complex or high‑risk quality issues.
- Identify, assess, and mitigate quality risks throughout the product life cycle.
- Collaborate closely with Technical Operations, Contract Manufacturing Organizations, contract testing labs, and distribution sites.
- Work cross‑functionally with Regulatory Affairs to ensure timely and accurate regulatory submissions.
Required profile
- Extensive experience leading quality oversight for clinical‑stage biopharmaceutical programs.
- Deep understanding of GMP, global Health Authority requirements, and quality system validation.
- Proven ability to develop and implement clinical and commercial quality strategies.
- Strong cross‑functional team leadership and project management capabilities.
Required skills
- Good Manufacturing Practice (GMP) knowledge
- Quality system validation
- Data integrity management
- Risk management and mitigation
- Batch disposition and investigation handling
- Analytical data review
- Regulatory compliance expertise
What we offer
- Opportunity to shape quality strategy for innovative cancer therapies.
- Collaborative environment with leading scientists and engineers.
- Competitive compensation and benefits package.
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Published 1 day ago
Expires 1 month from now
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ORIC Pharmaceuticals Inc.
San Diego