Director, Quality Assurance Leader
1 week ago
Job Title: Director, Quality Assurance
Company: GQR
Job Summary:
We are seeking an experienced professional to lead our Quality Assurance team as Director, Quality Assurance. The successful candidate will provide oversight of contract service providers, develop and review quality agreements, lead batch disposition activities, and support future commercialization.
Key Responsibilities:
- Quality Agreement Development and Review: Develop and review quality agreements with contract service providers to ensure compliance with regulatory requirements.
- Batch Disposition: Lead batch disposition activities, including review of master and executed batch records, specifications, certificates of analysis, and analytical test data.
- Quality System Development and Implementation: Develop, implement, and maintain quality systems, including disposition, vendor management, deviations, change control, and CAPA.
- Regulatory Compliance: Ensure compliance with cGMP, ICH, FDA, and EU regulations.
- Team Leadership: Lead and manage a team of quality assurance professionals to ensure effective quality systems and processes.
- Communication and Collaboration: Foster open communication and collaboration between stakeholders, including contract service providers, internal teams, and senior management.
Requirements:
- Education: BS/BA degree or MS degree in a scientific discipline.
- Experience: At least 10+ years of pharmaceutical or biotechnology industry cGMP experience, including 5+ years of experience in positions of management responsibility within Quality Assurance.
- Skills: Strong knowledge of cGMP, ICH, FDA, and EU regulations, direct experience working with contract service providers, and prior global commercial experience.
What We Offer:
GQR offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
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