Senior Director / Executive Director, Quality Control

Crescent Biopharma , Inc. • Waltham, MA

2d • $250,000 - $305,000

About The Position

Crescent Biopharma is seeking an accomplished Senior Director / Executive Director of Quality Control (QC) to provide strategic, scientific, and operational leadership for the QC function across the company’s biologics pipeline. This role will own the end‑to‑end QC strategy, including analytical control strategy, externalized QC operations, and regulatory readiness from early clinical development through late‑stage development and commercialization.
The ideal candidate is a seasoned QC leader with deep expertise in analytical method lifecycle management, strong experience overseeing global CDMOs and contract laboratories, and a proven ability to build scalable, phase‑appropriate QC systems in a lean biotech environment. This role will be a key member of the CMC/Tech Ops leadership team and a critical partner to QA, Regulatory, and Program Leadership.

Requirements

• 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.

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.

Benefits

• 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.
• Competitive compensation, including base salary, performance bonus, and equity.
• 100% employer-paid benefits package.
• Flexible PTO.
• Two, one-week company-wide shutdowns each year.
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree