Senior Product Quality Manager

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company; Boston (MA); On-site; USD 105,000 - 150,000; Full time

Benefits offered by this job

401(k) plan

company-sponsored medical

dental

vision

life insurance

generous paid time off

health and wellness program

Job summary

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, seeks a Manager, Product Quality in Boston, MA to provide quality oversight across the product lifecycle from clinical development through commercial readiness.

Reporting to the Executive Director, GMP Quality Assurance, you will partner with Technical Operations, CMC Development, Regulatory Affairs, and external CMOs to ensure robust quality systems, risk management, and regulatory readiness in a fast-paced,

Qualifications

• Bachelor's degree in Chemistry, Biology, pharmaceutical sciences, engineering, or related field.
• Advanced degree preferred.

Responsibilities

• Serve as Product Quality lead for assigned development programs.
• Provide quality support for drug substance, drug product, and finished product manufacturing activities.
• Ensure product quality risks are identified, assessed, and mitigated throughout development.
• Participate in cross-functional project teams and represent Quality in development and manufacturing discussions.
• Review manufacturing documentation, batch records, protocols, reports, and supporting quality documentation.
• Support technology transfers, process scale-up activities, process validation efforts, and manufacturing investigations.
• Partner with Technical Operations and external manufacturing organizations to resolve product quality issues.
• Review analytical results and product quality data to ensure compliance with specifications and requirements.
• Review and approve deviations, investigations, CAPAs, and change controls.
• Facilitate risk assessments and root cause analyses.
• Ensure quality events are appropriately investigated and completed within established timelines.
• Monitor quality trends and identify opportunities for proactive improvement.
• Contribute quality input to regulatory filings including INDs, IMPDs, CTAs, BLAs, and NDAs.
• Support responses to regulatory agency questions and requests.
• Participate in inspection readiness activities and support Health Authority inspections and audits.
• Maintain awareness of evolving global regulatory requirements impacting product quality.
• Support quality oversight of CMOs, CDMOs, laboratories, and other GMP service providers.
• Participate in supplier qualification activities and quality reviews.
• Review quality agreements and support ongoing supplier performance monitoring.
• Collaborate with external partners to ensure compliance with applicable GMP requirements.
• Support implementation of quality metrics and monitoring programs.
• Identify opportunities to improve quality processes and increase operational efficiency.
• Promote a culture of quality, compliance, accountability, and continuous improvement.

Skills

Quality Oversight

GMP Knowledge

Regulatory Submissions

Risk Management

Stakeholder Management

Education

Bachelor's degree

Advanced degree preferred

Job description

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, seeks a Manager, Product Quality in Boston, MA to provide quality oversight across the product lifecycle from clinical development through commercial readiness.

Reporting to the Executive Director, GMP Quality Assurance, you will partner with Technical Operations, CMC Development, Regulatory Affairs, and external CMOs to ensure robust quality systems, risk management, and regulatory readiness in a fast-paced,