Manager, Product Quality

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company•Boston, MA

2h•$105,000 - $150,000•Onsite

About The Position

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026. The Manager, Product Quality will provide quality oversight and support for product development and manufacturing activities across the Company portfolio. This role is responsible for ensuring quality considerations are integrated throughout the product lifecycle, from clinical development through commercial readiness. Reporting to the Executive Director, GMP Quality Assurance, this individual will serve as a key quality partner to Technical Operations, CMC Development, Regulatory Affairs, Clinical Supply Chain, and external manufacturing organizations. The role requires strong technical knowledge, sound judgment, and the ability to effectively manage quality activities in a fast-paced, outsourced development environment.

Requirements

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or other scientific discipline required.
Minimum 8+ years of quality experience within biotechnology, pharmaceutical, or related regulated industries.
Experience supporting clinical-stage products required.
Experience working with external manufacturing organizations required.
Strong understanding of cGMP regulations and ICH guidance.
Working knowledge of pharmaceutical manufacturing, analytical testing, validation, and product lifecycle management.
Strong problem-solving and risk-management skills.
Excellent communication and stakeholder management capabilities.
Ability to thrive in a collaborative, matrixed organization.

Nice To Haves

Advanced degree preferred.
Experience supporting regulatory submissions and inspections preferred.
Small molecule development experience preferred; biologics experience a plus.

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 appropriately 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 impacting product quality.
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.