Senior Manager/ Associate Director GMP Quality

Senior Manager / Associate Director, GMP Quality Location: Boston, MA (preferred; remote possible) Reporting to: Director, GMP Quality The position will be responsible for day‑to‑day operational support to ensure compliance with current Good Manufacturing Practices (cGMP) for all clinical and commercialization activities. This role will perform GMP operations, including clinical trial material manufacturing, QC testing, distribution, validation, and assist in the transition to commercial‑scale production. The incumbent partners and collaborates with internal and external teams to align on quality standards and ensure timely execution of all deliverables. Key Responsibilities GMP Quality Oversight: Point of contact for GMP Quality Operations function for clinical manufacturing, distribution, validation and commercialization activities. Support tech transfer as applicable. Ensure compliance with regulatory guidelines (FDA, EMA, ICH, etc.) and Quality Agreements. Regulatory Compliance: Support regulatory inspections and audits (FDA, EMA, etc.). Supplier & CMO Management: Provide quality oversight of external manufacturers, CMOs, and suppliers to ensure compliance with GMP standards. Quality Systems & Compliance: Oversee investigations related to deviations and product quality issues, ensuring timely resolution, root‑cause analysis and CAPA implementation. Serve as point of contact for third‑party supplier and CMO quality events and input quality documents into the eQMS. Inspection Readiness: Support functional groups to perform inspection readiness activities and oversee vendor inspection readiness. Documentation Management: Author, review, and approve GMP documentation, including batch records, release specifications, QC data, protocols, validation reports, etc. Risk Management: Identify and mitigate quality risks within clinical development and pre‑commercialization activities. Cross‑Functional Collaboration: Partner with CMC, Supply Chain, Commercial and Regulatory Affairs teams to ensure quality compliance throughout the product lifecycle from clinical trials to commercial manufacturing. Qualifications Bachelor’s degree in Life Sciences, Engineering, or a related field. Minimum 8 years of experience in quality operations, quality assurance or GMP manufacturing within the biotechnology or pharmaceutical industry. Experience with Phase 3 clinical trials and the transition to commercialization is highly preferred. Expertise in GMP, regulatory requirements, and industry best practices (FDA, EMA, ICH). Ability to collaborate with cross‑functional teams and manage complex initiatives. Excellent knowledge of quality systems, documentation and compliance management. Exceptional problem‑solving, troubleshooting and analytical skills. Strong communication and presentation skills, both written and verbal. Ability to work effectively in a remote, fast‑paced, evolving environment. Salary The salary range for Senior Manager GMP Quality is expected to be between $160,000 and $175,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job‑related skills, experience, education or training, market factors, and work location. The salary range for Associate Director GMP Quality is expected to be between $175,000 and $200,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job‑related skills, experience, education or training, market factors, and work location. Benefits We support our team with comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well‑being so you can thrive at work and beyond. Equal Employment Opportunity As an equal‑opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. #J-18808-Ljbffr Vor-Bio