Associate Director, Product Quality Assurance

Beam Therapeutics

Beam Therapeutics seeks an Associate Director of Product Quality Assurance to oversee quality operations for internal and external manufacturing and analytical activities supporting gene editing therapeutic programs. The role manages relationships with contract manufacturing and testing partners, ensures GMP compliance, and directs quality systems as the company advances products through clinical development.

Responsibilities

Provide quality oversight for internal analytical testing and external CDMO/contract testing laboratory operations
Manage quality relationships and interfaces with external manufacturing and testing partners
Oversee analytical method and instrument qualification/validation activities for internal testing
Lead investigations of quality deviations and ensure timely closure of audit findings and corrective actions
Review and approve batch records, release documentation, and manufacturing/analytical records for product release

Requirements

Extensive experience in pharmaceutical or biotechnology quality assurance and GMP operations
Demonstrated expertise in analytical method validation and instrument qualification
Strong knowledge of contract manufacturing organization (CMDO) oversight and quality management
Experience leading quality investigations, corrective actions, and regulatory compliance activities
Proven ability to develop and implement quality systems and risk mitigation strategies
Bachelor's degree in chemistry, life sciences, or related field; advanced degree preferred

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Vacancy posted 4 days ago

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