Crescent Biopharma · 7 hours ago
Senior Director / Executive Director, Quality Control
Waltham, MA
Full-time
Onsite
Director/Executive
$250K/yr - $305K/yr
15+ years expCrescent Biopharma is a leading oncology company focused on developing innovative therapies for cancer patients. They are seeking a Senior Director / Executive Director of Quality Control to provide strategic leadership for the QC function across the company's biologics pipeline, ensuring compliance and operational excellence throughout clinical development and commercialization.
BiotechnologyHealth CareMedical Device
Responsibilities
Define and lead Crescent’s global QC strategy across all development stages, ensuring alignment with overall CMC and corporate objectives
Establish and evolve a phase appropriate analytical control strategy to support clinical development, regulatory filings, and future commercialization
Serve as a QC subject matter expert and thought partner to senior leadership
Oversee the qualification, validation, and lifecycle management of analytical methods for biologics, including potency, purity, identity, and safety assays
Provide executive oversight of method transfers, method readiness, and routine testing execution at CDMOs and contract laboratories
Ensure compliant execution of release, stability, and in process testing in accordance with GMP requirements, Crescent standards, and global regulatory expectations
Lead selection, governance, and performance management of external QC vendors, ensuring technical excellence, compliance, and reliable delivery
Oversee QC related investigations at CDMOs, including OOS/OOT, deviations, CAPAs, and change controls
Review and approve key QC deliverables, including analytical protocols, validation reports, method transfer reports, and Certificates of Analysis
Partner closely with Process Development, MSAT, QA, Regulatory Affairs, and Program Teams to ensure QC strategies support product understanding and overall control strategy
Provide leadership and technical input into CMC and analytical sections of regulatory submissions (IND, IMPD, BLA/MAA)
Support interactions with global health authorities as a QC and analytical expert
Establish and continuously improve QC systems, procedures, and governance models suitable for a lean, scalable organization
Ensure strong data integrity, GMP compliance, and inspection readiness across all QC activities
Build, mentor, and develop internal QC capabilities as the organization grows
Own QC budgets, forecasting, and long-range planning
Qualification
Required
B.S., M.S., or Ph.D. in Biology, Biochemistry, Immunology, Analytical Sciences, or a related discipline
15+ years of progressive experience in biologics analytical development and Quality Control, with significant leadership responsibility
Demonstrated expertise in analytical method validation, lifecycle management, and control strategy development
Extensive experience managing externalized QC models and global CDMOs
Strong knowledge of GMP, data integrity principles, and ICH guidelines (Q2, Q5, Q6, Q14)
Proven experience supporting late‑stage development and regulatory filings and engaging with health authorities
Track record of building QC organizations and processes in small or virtual biotech environments
Excellent leadership, communication, and cross‑functional influencing skills
Benefits
100% employer-paid benefits package.
Flexible PTO.
Two, one-week company-wide shutdowns each year.
Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment.
Medical, dental, vision, life insurance, short- and long-term disability.
Company’s savings plan (401(k)).
Long-term incentive program.
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.
Company
Crescent Biopharma
Crescent Biopharma is a biotechnology firm focused on developing novel precision-engineered medicines.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$585MKey Investors
Fairmount Funds Management
2025-12-04Post Ipo Equity· $185M
2025-06-16Post Ipo Equity· $200M
2025-06-16IPO
Recent News
2026-01-06
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