Associate Director of Quality Control

Associate Director Of Quality ControlCaribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases.Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.Caribou is seeking an experienced and innovative Associate Director, Quality Control (QC), to lead key aspects of our QC strategy and operations. Reporting to the VP of Quality, this individual contributor will oversee QC testing and data management programs, serve as a key interface with contract labs and manufacturing partners, and ensure compliance with global regulatory standards. While this is currently an individual contributor role, the ideal candidate will demonstrate strong leadership potential and the ability to grow into a people management role as the QC function expands. This hybrid position is based in Berkeley, CA, with an expectation of being on-site up to three days per week, with flexibility as needed.Key ResponsibilitiesLead the development, review, and approval of raw material, in-process, and drug product specificationsGenerate, review and approve Certificates of Analysis (CoA) and Certificates of Test (CoT)Represent QC in Specification Review Committees and ensure alignment across functionsOversee QC testing conducted at internal and external labs (CDMOs, CTLs)Provide QC leadership for analytical tech transfers and method qualificationsEnsure timely, phase-appropriate execution of QC activities in alignment with cGMP and project/business needsAct as QC SME for regulatory filings, inspections, committees, and change control processesLead, review and approve investigations (as they relate to QC testing: OOS, OOT, deviations, etc.) and associated CAPAsSupport implementation and oversight of compliant electronic systems (e.g., LIMS, ELN)Design and manage stability programs compliant with ICH guidelinesOversee retain/reserve sample and trending programsAnalyze QC data trends to identify areas for continuous improvementCollaborate with cross-functional stakeholders including QA, QS, Regulatory, Manufacturing, Analytical & Process Development, and Supply Chain.Represent QC during regulatory inspections and external auditsPresent data and recommendations clearly to technical and non-technical audiencesDemonstrate readiness to lead and develop a growing QC team in the futureContribute to organizational design discussions and workforce planning within the Quality functionSupport mentoring and onboarding of new team members as neededKey CompetenciesTechnical Expertise in cell therapy QCCross-functional Project LeadershipExternal Partner and Vendor OversightRegulatory Intelligence and Compliance (FDA, EMA, ICH, Data Integrity)Data Analysis, Trending, control charting (LIMS, SPC, Excel, PwrPt., JMP or equiv).Scientific Rigor and Quality MindsetOptimization and Efficiency: 5S, Lean, and KaizenEffective Written (incl. technical) and Verbal Communication (incl. presenting in person and virtual meetings)Leadership Potential and Talent DevelopmentRequired QualificationsBS in Life Sciences or related field with 10+ years QC/analytical experience in biologics, cell therapy, or gene therapy; or MS/PhD with 6+ years of relevant experienceDeep experience in specification management, analytical method transfer, stability programs, and regulatory submission supportStrong working knowledge of cGMPs, 21 CFR Part 11, and global regulatory requirementsDemonstrated ability to lead cross-functional projects and readiness to grow into people managementExperience managing CDMOs/CTLs and navigating regulatory inspectionsPreferred QualificationsExperience in a clinical-stage or start-up biotech environmentExperience authoring CMC sections of BLAs or MAAsKnowledge of potency assays and immuno-oncology assaysBackground in cell engineering or synthetic biologyCaribou compensation and benefits include:Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employeesSalary Range: $187,000 to $200,000 - This represents the present low and high end of the Company's pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performanceGenerous paid vacation time, in addition to company-observed holidaysExcellent medical, dental, and vision insurance401(k) retirement savings plan, which includes matching employer contributionsEmployee stock purchase plan (ESPP)Tuition reimbursement programThe benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, hair texture or type or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc. for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc. will not be obligated to pay any referral or placement fee.