Associate Director, GMP Quality & Regulatory Oversight

Beam Therapeutics Inc.; Cambridge (MA); On-site; USD 180,000 - 230,000; Full time

Job summary

Beam Therapeutics Inc. seeks an Associate Director of Product Quality Assurance to lead phase-appropriate quality oversight of GMP operations, including internal testing and external manufacturing partners.

The role drives risk management, investigations and release activities to support Beam’s transition from discovery to clinical development and commercial launch. The incumbent will oversee analytical method validation, vendor relationships, and ensure compliance with global cGMP standards

Qualifications

• 12+ 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, detail-oriented personality and ability to work and drive change across functions.
• 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.

Responsibilities

• Oversee all aspects of Quality related to GMP operations and external partners (CDMOs, CTLs) and internal analytical operations.
• Provide quality oversight to support early phase GMP activities and ensure compliance.
• Lead interface with CDMOs and other external partners from a quality perspective.
• Develop and implement risk analyses, corrective actions and preventive actions.
• Ensure systems for product release documentation and batch records review are robust.
• Provide leadership and direction to staff in line with cGMP and Beam policies.
• Coordinate investigations and drive closure with cross-functional teams.
• Support GxP auditing of contract service providers.

Skills

Verbal and written communication

Leadership and people management

Attention to detail

Cross-functional collaboration

Change management

Vendor management

GxP knowledge

Education

Bachelor's or Advanced degree in a scientific discipline

Job description

Beam Therapeutics Inc. seeks an Associate Director of Product Quality Assurance to lead phase-appropriate quality oversight of GMP operations, including internal testing and external manufacturing partners.

The role drives risk management, investigations and release activities to support Beam’s transition from discovery to clinical development and commercial launch. The incumbent will oversee analytical method validation, vendor relationships, and ensure compliance with global cGMP standards