Product Quality Manager, Biotech Drug Development

Centessa Pharmaceuticals; Boston (MA); On-site; USD 105,000 - 150,000; Full time

Job summary

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly, is a clinical-stage company advancing orexin receptor 2 agonists for narcolepsy and sleep-wake disorders. The Manager, Product Quality will provide quality oversight across the portfolio, ensuring quality considerations are integrated from clinical development through commercial readiness.

Reporting to the Executive Director, GMP Quality Assurance, this role partners with Technical Operations, CMC Development, Regulatory Affairs,

Qualifications

• Bachelor's degree in Chemistry, Biology, or related field required; advanced degree preferred.
• Minimum 8+ years of quality experience in biotech/pharma.
• Experience supporting clinical-stage products and external manufacturers.
• Strong understanding of cGMP regulations and ICH guidance.

Responsibilities

• Provide quality oversight for development programs and manufacturing activities.
• Review batch records, protocols, reports, and quality documentation.
• Support tech transfer, process scale-up, validation, investigations.
• Support regulatory submissions and inspections.
• Collaborate with external partners to ensure GMP compliance.
• Monitor quality trends and drive continuous improvement.

Skills

Quality oversight

Regulatory understanding

Risk management

Communication

Education

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related field

Job description

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly, is a clinical-stage company advancing orexin receptor 2 agonists for narcolepsy and sleep-wake disorders. The Manager, Product Quality will provide quality oversight across the portfolio, ensuring quality considerations are integrated from clinical development through commercial readiness.

Reporting to the Executive Director, GMP Quality Assurance, this role partners with Technical Operations, CMC Development, Regulatory Affairs,