Senior Manager, Quality Assurance

Location
Menlo Park, CA, US
Posted
Apr 12, 2019
Ref
CCA4F89BD2
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Location: Menlo Park, California, United States

Reporting to: Senior Director Quality Assurance

Job summary

The Senior Manager, Quality Assurance will support the Senior Director Quality Assurance for QA support of Orchard's Lentiviral Vector manufacturing.

Responsibilities
  • Review and approve master batch records, master labeling/packaging records, product specifications and other process related documents from contract sites.
  • Perform batch release through batch record and data review/approval and managing change controls and 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.
  • Write, revise and periodically review SOPs to further develop the Quality System and control over the quality of vendor services and products.
  • Review and approve manufacturing and analytical validation and technology transfer protocols and reports.
  • Review and approve product stability reports.
  • Assist in the QC review of various documents, including regulatory dossiers and reports.
  • As appropriate, attend project meetings and provide development quality input and lead the resolution of quality-related issues.
  • Clearly communicate issues to vendors and Orchard Therapeutics management in a timely basis.
  • Supports the preparation, coordination, and management of regulatory agency Preapproval or regular inspections as required.
  • Support regulatory inspections; internal and external
  • Provides Quality Assurance leadership, guidance, and direction for the manufacture of vector consistent with CGMPs and Orchard Therapeutics quality compliance best practices.


Requirements
  • Bachelor's degree in scientific discipline such as chemistry, biology or equivalent
  • Working knowledge of US and EU CGMPs
  • Minimum 10 years' experience in the pharmaceuticals/bio pharm manufacturing industry with at least 5 of those years at the QA Manager level or equivalent
  • Experience working with Quality Systems in support of both early and late stage development programs.
  • Willingness to travel, approximately 20% as needed.