New · posted Oct 15
Centessa Pharmaceuticals (UK) · Pharmaceuticals
Manager, Product Quality
- Boston, MA
- On-site
- Full-time
- Manager
Open until filled
The role
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.
Work Location
The Manager, Product Quailty role is based in the US, with occasional travel.
What you need
- 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.
What you'll do
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.
Pay and benefits
$105,000 – $150,000 a year
Employer providedThe 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 an 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
401(k) plan
Medical, dental, vision and life insurance
Generous paid time off
Health and wellness program
Discretionary annual bonus
Where you'll work
Boston, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Boston, MAEqual opportunity, accessibility and legal noticesCentessa Pharmaceuticals (UK)'s statements, word for word
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.
Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 17% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in Massachusetts18 roles publishing pay
Manager roles in the US105 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $105,000 | — | $150,000 |
| Massachusetts (middle half) | $116,500 | $133,250 | $153,000 |
| All US (middle half) | $126,000 | $153,000 | $167,500 |
This role: Centessa Pharmaceuticals (UK)'s own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Centessa Pharmaceuticals (UK)'s own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 39 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance8
- Quality systems and risk6
- Collaboration and leadership6
- Investigations and CAPA5
- Lab testing and methods3
- Validation and qualification3
- Regulatory submissions3
- Documentation and SOPs1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
Company hiring pulse
Centessa Pharmaceuticals (UK) on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 2
- Locations
By discipline
- Regulatory3 50%
- Quality3 50%
By level
- Director5 83%
- Manager1 17%
More roles at Centessa Pharmaceuticals (UK)
- View role
Associate Director, Clinical Quality Assurance
Boston, MADirectorPharmaceuticals$140K–$180K
- View role
Director, External Quality Control & Stability
Remote, USDirectorPharmaceuticals$150K–$210K
- View role
Senior Director, Regulatory CMC
Boston, MADirectorPharmaceuticals$175K–$260K
- View role
Associate Director, Regulatory Project Management
Boston, MADirectorBiotechnology$140K–$200K
Similar Quality Assurance roles elsewhere
- View role
Manager, GMP Quality Operations
Viking TherapeuticsSan Diego, CAManagerPharmaceuticals$110K–$135K
- View role
QA OPS Manager B79 Viral PCU Lead
SanofiSwiftwater, PAManagerPharmaceuticals$113K–$164K
- View role
Transcend GTO-QM, Commercial Quality
Johnson & JohnsonTitusville, NJ · HybridManagerPharmaceuticals$122K–$213K
- View role
Senior Manager, GCP Quality Assurance
Madrigal PharmaceuticalsRemote, PennsylvaniaManagerPharmaceuticals$147K–$180K
Manager, Product Quality at Centessa Pharmaceuticals (UK)
Open until filled. $105K–$150K a year, employer provided.