Senior Manager, Quality Assurance

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.