New · posted Oct 15
Crescent Biopharma · Biotechnology
Director/Senior Director, GMP Quality Assurance Operations
- Waltham, MA
- On-site
- Full-time
- Director
Open until filled
The role
Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
We are seeking a Director/Senior Director, GMP Quality Assurance Operations. You will be responsible for providing strategic and hands-on GMP Quality leadership for manufacturing activities supporting the lead biologics program and future pipeline growth. Partnering closely with the GMP Quality and cross-functional Technical Operations teams, you will ensure reliable clinical supply while building the Quality infrastructure needed to successfully advance programs into late-stage development and commercialization.
You will provide Quality oversight across master cell bank, working cell bank, drug substance, drug product, and finished goods within a global outsourced manufacturing network. You will bring deep biologics experience spanning clinical through late-stage development, with demonstrated expertise supporting clinical supply, technology transfer, CDMO selection and management, process validation/PPQ, and commercial readiness, including BLA support.
What you need
- Bachelor’s degree in life sciences or a related discipline; advanced degree preferred.
- Director: 8-10 years of progressive experience in GMP Quality Assurance within biotech or pharmaceutical development.
- Senior Director: 10-12 years of progressive experience with demonstrated leadership in GMP QA Operations.
- Strong working knowledge of global GMP regulations and guidance (FDA, EMA, ICH) and phase-appropriate application for biologics spanning clinical-stage through late-stage development.
- Deep, hands-on experience supporting biologics manufacturing, including drug substance and drug product operations, from clinical through late-stage/commercial; experience with ADCs or complex modalities is a plus.
- Proven experience providing QA oversight of CDMOs, including selection, audits, investigations, change management, and issue resolution; experience leading tech transfers and supporting PPQ and BLA filings strongly preferred.
- Experience supporting regulatory submissions and inspections, including preparation of CMC-related documentation and responses to health authority questions.
- Solid understanding of validation principles, batch release processes, and analytical and stability programs.
- Demonstrated ability to balance a high volume of ongoing clinical resupply and release activities with the strategic work of preparing a program for phase 3/commercial readiness.
- Demonstrated ability to operate effectively in a highly outsourced, fast-paced development environment with evolving priorities.
- Strong collaboration, communication, and influencing skills, with the ability to balance compliance rigor and development agility.
- Hands-on, solutions-oriented mindset with the judgment to escalate issues appropriately and propose pragmatic, risk-based solutions.
- Right attitude and aptitude for a small company environment—self-starting, comfortable with ambiguity and wearing multiple hats, and driven to get things done with both high quality and speed.
- Willingness and ability to travel to CDMO and other supplier sites for PIP, PPQ execution, and other on-site quality activities as needed.
- Commitment to fostering a culture of quality, integrity, inclusion, and continuous improvement.
What you'll do
Pay
$200,000 – $260,000 a year
Employer providedThe salary range for this position is $200,000 to $260,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
Where you'll work
Waltham, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Waltham, MAEqual opportunity, accessibility and legal noticesCrescent Biopharma's statements, word for word
Additional Description for Pay Transparency
The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits
Please note:
Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.
Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 10% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in Massachusetts33 roles publishing pay
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $200,000 | — | $260,000 |
| Massachusetts (middle half) | $186,000 | $204,500 | $231,000 |
| All US (middle half) | $186,500 | $209,250 | $231,375 |
This role: Crescent Biopharma'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 Crescent Biopharma's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance8
- Collaboration and leadership5
- Regulatory submissions4
- Validation and qualification3
- Quality systems and risk3
- Lab testing and methods2
- Documentation and SOPs2
- Investigations and CAPA2
- Data and digital systems1
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
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- 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
Company hiring pulse
Crescent Biopharma on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Quality2 67%
- Regulatory1 33%
By level
- Director3 100%
More roles at Crescent Biopharma
- View role
Director/Senior Director, QMS, Digital QA and GxP Compliance
Waltham, MADirectorBiotechnology$200K–$260K
- View role
Executive Director, Regulatory Affairs CMC
Waltham, MADirectorBiotechnology$290K–$323K
Similar Quality Assurance roles elsewhere
- View role
Director, Quality Systems
Wave Life Sciences USALexington, MA · HybridDirectorBiotechnology$193K
- View role
Director, Corporate Quality
UniQure Biopharma B.V.Lexington, MA · HybridDirectorBiotechnology$205K
- View role
Director/Senior Director, GCP Quality Assurance
Tango TherapeuticsBoston, MA · HybridDirectorBiotechnology$171K
- View role
Director, Corporate Quality - GCP
Sarepta TherapeuticsBedford, MA · HybridDirectorBiotechnology$186K–$232K
Director/Senior Director, GMP Quality Assurance Operations at Crescent Biopharma
Open until filled. $200K–$260K a year, employer provided.