Senior Manager, GMP Quality Operations

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

Responsible for quality oversight of external GMP Quality operations and support for clinical-stage lentiviral-based gene therapies, and the various activities in the disposition of clinical final product. This includes Review and approve non-conformance and CAPA issues, as well as approve and monitor the status of GMP related deliverables from external manufacturers.

The individual will be responsible for supporting our internal team responsible for overseeing a network of global contract manufacturers and providing GMP Quality oversight both internally and externally.

Cambridge
Quality
Feb 8 2021
Key Responsibilities
  • Review and approve master batch records, master labeling/packaging 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.
  • Review and approve manufacturing aseptic qualification protocols and reports.
  • Assist in the development and tracking of Quality metrics. Prepare metrics for the Management Review and Annual Product Review.
  • Assist in the QC review of various documents, including regulatory dossiers and reports.
  • Proactively and effectively communicate with contract manufacturers to address and resolve complex and routine activities while building positive client/vendor relationships, fostering continuous improvement, and adding value to our internal CMC team.
  • Supports the preparation, coordination, and management of regulatory agency Preapproval or regular inspections.
  • Support regulatory inspections at contract sites involved in the project.
  • Provides Quality Assurance leadership, guidance, and direction to CMOs consistent with cGMPs and AVROBIO quality compliance.
Minimum Requirements/ Qualifications
  • Bachelor’s degree in a scientific field.
  • Minimum of 10+ 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.
  • Demonstrated capability on building effective relationships with CMOs.
  • Good Clinical Practice experience is Gene therapy experience desired, but not required.
  • Excellent verbal and written communication skills to effectively communicate with site staff and vendors.
About AVROBIO

AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

AVROBIO, Inc is an EEO employer