We are partnered with an innovative biotechnology company focused on advancing cutting-edge treatments. They are dedicated to improving the lives of patients through research, development, and commercialization of novel therapies. The Assistant Vice President of Quality Control (AVP, QC) will oversee the strategic direction, management, and continuous improvement of the company's quality control processes, ensuring compliance with regulatory standards and maintaining the highest level of product quality across all stages of development and commercialization.
Key Responsibilities:
- Lead and develop the Quality Control department, driving a culture of excellence, continuous improvement, and operational efficiency.
- Collaborate with senior leadership to define the long-term strategy for quality control operations.
- Ensure alignment of QC strategies with the company’s overall goals, ensuring timely and compliant product development and commercialization.
- Oversee the daily activities of the QC laboratories, ensuring that testing procedures, product releases, and documentation comply with regulatory requirements (e.g., FDA, EMA, ICH, etc.).
- Ensure the appropriate validation of analytical methods, testing systems, and equipment.
- Provide oversight for the review and approval of QC testing documentation, including raw data, reports, and Certificates of Analysis (COA).
- Ensure the effective implementation of a robust change control process within QC operations.
- Maintain a comprehensive understanding of global regulatory requirements (e.g., GMP, GLP, ISO standards) and ensure all QC operations comply with these regulations.
- Manage the preparation and execution of internal and external audits, inspections, and regulatory submissions.
- Act as a key contact during regulatory inspections and audits, providing oversight and ensuring timely resolution of any findings.
- Mentor and develop a high-performing team of QC professionals, fostering a culture of innovation, accountability, and professional growth.
- Establish performance metrics, conduct regular performance evaluations, and implement training programs to ensure team members are up-to-date on current industry best practices and regulatory changes.
Experience:
- Ph.D. in Life Sciences (e.g., Biology, Biochemistry, Biotechnology, Chemistry, Pharmaceutical Sciences) or related field.
- Minimum of 12 years of experience in the biotechnology or pharmaceutical industry with at least 6 years in a leadership role in Quality Control
