Associate Director, Product Quality Assurance

The role

The Associate Director of Product Quality Assurance provides phase appropriate quality oversight for internal and external manufacturing and analytical activities. This includes managing CDMO relationships and overseeing analytical instrument and method qualification.

What you will do

• Provide quality oversight for external GMP operations and internal analytical operations.
• Manage core interface and relationships with CDMOs and external partners.
• Develop solutions and drive risk analysis and mitigation strategies.
• Create and ensure quality systems for analytical testing and product release.
• Ensure systems are in place for following up and closing investigations and audit observations.
• Analyze exceptions for corrective preventative actions and product impact.
• Provide technical expertise for quality decisions.
• Evaluate facility, procedures, equipment, personnel and processes.
• Oversee analytical method and instrument qualification and validation.
• Provide leadership, guidance, and direction to staff consistent with cGMP.

Required qualifications

• Bachelors or Advanced degree in a scientific discipline.
• 10+ years experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and quality.
• Must have Biologics experience.
• 3+ years of Quality management experience with a successful track record in managing CDMOs as well as internal QA systems in a virtual environment.
• Understanding of worldwide requirements of cGMP and quality systems for commercial and clinical products.
• Excellent verbal and written communication skills.
• Experience interacting with regulatory health authorities at pre- and post-approval inspection.
• Established expertise and training in GxP systems.
• Ability to evaluate Quality Systems and drive value added enhancements.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Excellent team building, leadership and management skills.

About the company

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. The company uses base editing technology to advance a diversified portfolio of base editing programs.