Senior Manager, GMP Quality Operations & Compliance

Our culture is entrepreneurial, inclusive and caring. We're passionate about our work. And we embrace a pioneering spirit. Join us as we strive to develop innovative therapies with the power to give people with genetic diseases freedom for life.

Senior Manager, GMP Quality Operations & Compliance

The Senior Manager of GMP Quality Operations and Compliance will be responsible for interfacing with global contract manufacturers and providing GMP Quality oversight both internally and externally related to the quality management system, audits, deviations, CAPAs, change control, while ensuring activities are performed according to applicable guidelines and regulations.

Cambridge
Quality
May 27 2021
Key Responsibilities
  • Quality oversight of clinical trial material manufacturing, including but not limited to: Review and approve master batch records, master labeling records, product specifications, stability protocols, stability reports, and other process related documents from contract sites. Perform batch disposition through batch record and data review/approval and managing process deviations for timely release.
  • Review and/or approve deviations, OOSs, CAPAs, change control in an efficient manner for adequate and timely closeout of these events for both internal and external GMP and CMC activities.
  • Review and approve manufacturing aseptic qualification protocols and reports.
  • Participate in vendor oversight activities.
  • Assist in the review and development of quality metrics
  • Assist in performance of internal audits, including audit plans and reports. Review and evaluate internal audit responses with current industry expectations to assure compliance.
  • Ensure vendor qualification and audit activities are appropriate documented, including maintaining audit files and ensuring approved supplier list is updated.
  • Support regulatory inspections internally or at contract sites involved in the project.
Minimum Requirements/ Qualifications
  • Bachelor’s degree in a scientific field.
  • Minimum of 5+ years of Quality Assurance/Manufacturing Operations experience in pharmaceutical or biotech industry.
  • In-depth knowledge of GMP and QA principles, practices, and standards; thorough understanding of FDA, EMA and ICH quality regulations.
  • Ability to build relationships with internal stakeholders and external vendor/partners, and influence across disciplines and all levels.
  • Highly motivated, flexible, with excellent organizational skills with keen attention to detail.
  • Strong team player with a solution oriented, customer service approach.
  • Experience in the operational Quality Management of (CMO) Contract Manufacturing Organizations producing products on behalf of another pharmaceutical company
  • Experience with Regulatory / Health Authority Inspections preferred
  • Demonstrated capability on building effective relationships with CMOs.
  • Experience is Gene therapy experience desired, but not required.
  • Excellent verbal and written communication skills to effectively communicate with site staff and vendors.
  • Ability to travel up to 25%
About AVROBIO

Our vision is to bring personalized gene therapy to the world. We aim to prevent, halt or reverse disease throughout the body with a single dose of gene therapy designed to drive durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our ex vivo lentiviral gene therapy pipeline includes clinical programs in Fabry disease, Gaucher disease type 1 and cystinosis, as well as preclinical programs in Hunter syndrome, Gaucher disease type 3 and Pompe disease. AVROBIO is powered by our industry leading plato® gene therapy platform, our foundation designed to deliver gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario.

AVROBIO, Inc is an EEO employer