Manager, Product Quality

Socket.dev; Boston (MA); On-site; USD 105,000 - 150,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life insurance

Generous paid time off

Wellness program

Job summary

Centessa Pharmaceuticals, a Boston-based clinical-stage company, is seeking a Manager, Product Quality to provide quality oversight across the product lifecycle. The role partners with Technical Operations, CMC, Regulatory Affairs, and external CMOs to ensure quality is integrated from clinical development through commercial readiness.

Reporting to the Executive Director, GMP Quality Assurance, this individual will lead risk assessments, CAPAs, change controls, and regulatory support while

Qualifications

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

Responsibilities

• Product Quality oversight for assigned development programs and manufacturing activities.
• Review manufacturing documentation, batch records, and quality documentation.
• Support technology transfers, process scale-up, validation efforts, and investigations.
• Review deviations, CAPAs, investigations, and change controls.

Skills

Problem-solving

Communication

Stakeholder management

Collaboration

Risk management

Education

Bachelor's degree in science

Advanced degree preferred

Job description

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.

Description of Role

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.

Key Responsibilities

Product Quality Oversight

• 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.

Manufacturing and Technical Operations Support

• 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.

Investigations, CAPAs, and Change Controls

• 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.

Regulatory and Inspection Support

• 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.

Supplier and CMO Management

• 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.

Continuous Improvement

• 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.

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or other scientific discipline required. Advanced degree preferred.
• 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.
• Experience supporting regulatory submissions and inspections preferred.
• Small molecule development experience preferred; biologics experience a plus.
• 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.

Work Location

The Manager, Product Quailty role is based in the US, with occasional travel.

Compensation

The annual base salary range for this position is $105,000.00 to $150,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge and location.

In addition to base pay, this role is eligible for a discretionary annual bonus. The Company also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

POSITION

Full-Time, Exempt

EEOC Statement

EEOC Statement: Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.