An innovative biotech company, specializing in oncology and autoimmune therapies, is seeking a Associate Director of Quality Control to lead QC operations and oversee product testing, ensuring the highest standards of quality for breakthrough treatments. This leader will drive quality control strategies, working cross-functionally to ensure compliance and maintain product integrity through all stages of the development lifecycle.
Key Responsibilities:
- QC Leadership: Oversee all quality control activities for oncology and autoimmune therapeutic products, ensuring compliance with GMP and regulatory standards.
- Team Development: Build, mentor, and manage a high-performing QC team, fostering a collaborative and quality-centric culture.
- Testing & Analysis: Supervise analytical testing, release testing, stability programs, and method validation for clinical and commercial products.
- Cross-Functional Collaboration: Partner with Manufacturing, Quality Assurance, and R&D to ensure a cohesive approach to product quality and regulatory standards.
- Continuous Improvement: Implement best practices in QC, including process improvements, risk mitigation strategies, and operational efficiencies.
Qualifications:
- Experience: 10+ years of quality control experience in biotech or pharma, with significant exposure to oncology and/or autoimmune products.
- Leadership: Proven track record in managing QC teams and building quality control systems in a regulated environment.
- Technical Expertise: Strong knowledge of analytical methodologies, FDA/EMA regulations, and ICH guidelines.
- Education: Bachelor's degree in a scientific discipline required; advanced degree preferred.