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Director, Quality Assurance
2 months ago
**Key Responsibilities:**
- Ensure compliance with regulatory requirements, including 21 CFR 210/211, 312, EudraLex Vol. 4, and ICH.
- Provide oversight and management of quality-related tasks and priorities for clinical and commercial vendors/partners.
- Develop and execute continuous quality assurance improvements.
- Lead the GMP QA department, providing guidance, development, and leadership.
- Manage material disposition and review/approve Master Batch Production & Packaging Records and Executed Batch Production & Packaging Records.
- Review and approve analytical data, including release data, specifications, and stability.
- Collaborate with internal stakeholders and partners on validation and technology transfer activities.
- Establish and maintain strategic business partnerships to ensure corporate deliverables are met.
- Support internal audit programs and regulatory inspections.
- Lead Clinical QP release activities and review pertinent CMC sections of regulatory submissions.
- Hire and manage QA employees.
**About Deciphera Pharmaceuticals:**
Deciphera Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative treatments for cancer and other diseases. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our products.
