Manager, External QA, Non-Sterile

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PURPOSE AND SCOPE OF POSITION:

The position provides Quality oversight for the selection of Contract Manufacturing Organizations (CMOs) used for the manufacture, bulk packaging, testing and distribution of Clinical Supplies in accordance with corporate policies, procedures and GMPs. The incumbent will cover multiple products at the CMOs and will report to the Associate Director, External QA Lead.

DUTIES AND RESPONSIBILITIES

• Oversees the Contract Manufacturing Organization’s Quality Management Systems:

  • Partner with Clinical Supply Operations (CSO) and Drug Product Development (DPD)/Chemical Product Development (CPD) to identify and qualify manufacturing facilities for the Manufacture, Bulk Packaging and testing of API and/or Clinical Drug Products.

  • Serves as the BMS Quality single point of contact for the assigned CMOs with responsibility for Quality and Compliance performance.

  • Ensures Deviations, Product Quality Complaints, Change Controls, Stability and CAPAs are managed in a compliant and timely manner.

  • Oversees vendor change control process and ensures that BMS products are manufactured in full compliance with all applicable regulations.

  • Implement the process to achieve Vendor Quality Qualification with appropriate continued monitoring to ensure maintenance of status.

  • Partners with CSO / DPD / CPD to identify Quality and Compliance risks and develop / implement plans to mitigate via a risk management approach.

• Quality Review and Approval of GMP Documentation:

  • Responsible for final Batch Disposition decisions: Reviews, in a timely manner, all batch and test documentation associated with Active Pharmaceutical Ingredients and/or Investigational Medicinal Products (IMPs) and releases those found in compliance into SAP and QMS as applicable.

  • Conducts, plans, schedules the review and approval of GMP records, data, and other release documentation as needed, intended for the manufacture of API and IMPs.

  • Reviews and approves documents related to Quality Systems such as master batch records, manufacturing and laboratory investigation reports, and other documents as needed.

  • Provides instruction and guidance on quality issues and serves as a resource for the site.

  • Participates in Corporate Vendor Audits/Visits as required.

  • Provides guidance to the CMC QA teams on quality issues.

  • Authors procedural documentation.

  • Coordinates and authors Quality Agreements.

  • Supports site operations during regulatory agency and third-party inspections as required.

  • Performs Vendor Quality Risk Assessments.

  • Performs other tasks as assigned.

EDUCATION AND EXPERIENCE

• BS/MS in a Scientific discipline, preferably in Chemistry, Pharmacy, 2-5 years’ experience in the Pharmaceutical industry in a technical or quality role and may be combined with other relevant Pharmaceutical industry experience.

• Periods spent in clinical or commercial manufacturing operations would be considered advantageous. Experience within a QA/QC environment is an asset. 

• Experience within R&D, including Chemical Development and/or Drug Product Development environment is an asset.

• Experience in the manufacturing of non-sterile drug product and drug substance.

• General knowledge of GMP operations and regulations.

Required knowledge, skills, abilities: 

• Decision-making regarding disposition for distribution of clinical trial materi