Associate Director, Quality Control

We are seeking an experienced Associate Director of Quality Control (QC) to lead QC operations across the company’s biologics pipeline.  You will report directly to the head of QC and will serve as key contributor in overseeing day-to-day QC activities and analytical testing at CDMOs and contract testing laboratories (CTLs). You must have deep expertise in stability, specification, reference standard programs management, analytical method transfer, qualification/validation. and a proven track record overseeing external testing labs in a GMP environment; you will also be responsible for ensuring robust, phase‑appropriate QC operations supporting Crescent’s biologics pipeline. This role is based in Waltham, MA and you must have experience in biotech.

Responsibilities

• Manage phase appropriate stability, specification and reference standard programs in support of early and late-stage products 
• Serve as QC point of contact for CDMOs/CTLs ensuring appropriate quality control oversight of manufacturing campaigns
• Ensure CDMOs/CTLs perform release, stability and in-process testing in accordance with GMP requirements, Crescent standards, and regulatory expectations.
• Generate COAs for intermediate material, Drug Substance/Drug Product and collaborate with QA to facilitate batch disposition
• Monitor CDMO/CTL stability studies, review of raw data and approval of stability summary reports
• Trend and evaluate stability data according to ICH in support of shelf life/expiry date assignment and extensions 
• Schedule, chair and facilitate stability review board meetings in support of stability data evaluation and assignment of product shelf-life
• Schedule, chair and facilitate stability review board in support of stability data evaluation and assignment of product shelf-life
• Schedule, chair and facilitate specification review board in support of new product specification and revisions
• Provide QC oversight for OOS/OOT investigations, deviations, CAPAs, and change control
• Review and approve specific sections of vendor batch records and other required documentation
• Collaborate with partners, CDMOs/CTLs to transfer, methods for release and stability testing as needed according to phase appropriate approach
• Participate in the qualification, validation, and lifecycle management of analytical methods.
• Support authoring and review of Module 3 sections of regulatory submissions (IND/IMPD/BLA).
• Ensure strong data integrity practices and compliance with GMP, ICH, and global regulatory guidelines.
• Assist in the establishment of QC systems, SOPs, and processes suitable for a lean and scalable operation.
• Participate in internal and external cross-functional meetings as QC representative and manage program timelines
• Provide leadership, mentoring, and technical development within the QC function.

Education & Experience

• B.S. or M.S. in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• Minimum 10 years of industry experience in biologics analytical development and QC.
• Deep expertise in method qualification, validation, and lifecycle management.
• Significant experience overseeing QC activities at CDMOs/CTLs.
• Strong understanding of GMP, data integrity principles, and ICH analytical guidelines (Q2, Q5, Q6, Q1E).
• Experience supporting Module 3 sections of regulatory submissions and interacting with health authorities.
• Experience with bioassay (Binding ELISA and Cell Based Potency (CBA) method development and life cycle management is a plus.
• Hands on experience using Microsoft Office, Veeva Vault QualityDoc, LIMS, and Statistical software such as GraphPad Prism, JMP.
• Demonstrated ability to lead QC operations in a small or virtual biotech environment.
• Strong communication, leadership, and cross‑functional collaboration skills.

What We Offer

• 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; also, two, one-week company-wide shutdowns each year
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities