Director of Quality Assurance

Director of Quality Assurance - Combination Product Join to apply for the Director of Quality Assurance - Combination Product role at 89bio. Special Advisory The FTC has an advisory out on the domain 89biocareers.com. If you are contacted by any group using a similar, but not our exact domain 89bio.com, please report any scams. Company Description 89bio is a clinical-stage biopharmaceutical company dedicated to the development of best‑in‑class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through Phase 3 clinical development for the treatment of metabolic dysfunction‑associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best‑in‑class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half‑life. The company is headquartered in San Francisco. The Role Reporting to the Executive Director, Quality Systems, the Director of Quality Assurance - Combination Product will lead quality activities related to combination products supporting our biologics pipeline. This is a hands‑on role in a small, agile company environment – ideal for someone who thrives in building and executing as much as directing. The successful candidate will play a critical role in ensuring commercial readiness, process performance qualification (PPQ) support, oversight of our prefilled syringe products, and the development and implementation of our auto‑injector delivery system. Additionally, this role will strengthen and mature the Combination Product Quality Management System (QMS) to meet regulatory expectations and enable successful product launch. The Responsibilities PPQ & Commercial Readiness Provide QA leadership for PPQ activities, ensuring compliance with global regulatory requirements (FDA, EMA, ICH, ISO 13485, 21 CFR 4). Support process validation and readiness for commercial manufacturing, including review and approval of validation protocols, reports, and associated quality documentation. Partner with CMC, manufacturing, and regulatory colleagues to enable smooth transition from late‑stage development to commercialization. Combination Product / Device Quality Lead QA oversight for device/auto‑injector development, qualification, and implementation. Ensure design control, risk management, human factors, and usability engineering are executed in compliance with applicable regulations and standards. Drive quality input into supplier qualification, component manufacturing, assembly, and testing of combination products. Quality Systems & Compliance Enhance and maintain the device/combination product QMS, aligning it with biologics GMP requirements. Manage change control processes related to biologics and combination product lifecycle activities, ensuring robust evaluation, documentation, and implementation of changes. Facilitate risk assessments (e.g., FMEA, fault tree analysis, risk ranking) across product development, manufacturing, and post‑market surveillance. Author, revise, and implement SOPs and procedures for device quality and combination product lifecycle management. Ensure readiness for health authority inspections and pre‑approval inspections (PAIs). Cross‑Functional Collaboration Partner closely with development, regulatory affairs, CMC, supply chain, and device engineering teams to ensure quality requirements are embedded early. Serve as a subject matter expert (SME) for combination product regulations and expectations. Provide training, coaching, and hands‑on QA support across functional areas. The Qualifications Bachelor’s or advanced degree in a scientific or engineering discipline (e.g., Chemistry, Biology, Engineering, or related field). 10+ years of relevant QA/Regulatory/CMC experience in the biopharmaceutical industry, including significant exposure to combination products, pre filled syringes, and auto injectors’ Deep understanding of global regulations and standards for combination products and biologics (e.g., 21 CFR Parts 210, 211, 4, 820; ISO 13485; EU MDR). Hands‑on experience supporting auto‑injector or pre‑filled syringe development preferred. Proven track record of leading PPQ, validation, change control, risk assessment, and commercial readiness activities. Ability to work independently and effectively in a lean, small‑company environment, where strategic leadership is balanced with tactical execution. Strong organizational skills, problem‑solving ability, and attention to detail. Excellent communication skills (written and verbal), with the ability to influence and build consensus across teams and external partners. Salary & Level 89bio considers a range of factors when determining salary and level. These considerations mean actual salary and level may vary. The expected salary range for this position based on the primary location in Northern California is $230,000 - $240,000. The Perks Competitive health insurance coverage Women’s forum / mentoring Office based in the heart of San Francisco, near plenty of shops and restaurants Fun opportunities to engage with co‑workers in person and remotely Conditions of Employment Background investigations are required for all positions by 89bio, consistent with applicable law. Candidates must already hold work authorization, as visa sponsorship is not available for this role. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. 89bio is committed to the full inclusion of all qualified individuals. As part of this commitment, 89bio will ensure that persons with disabilities are provided reasonable accommodations for the hiring process, and/or to perform essential job functions where the requested accommodation does not impose an undue hardship. Notice to Recruiters: To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team. #J-18808-Ljbffr