Description:
Bristol-Myers Squibb External Manufacturing is seeking to recruit a permanent QA Manager. This person is accountable to provide quality operations and compliance oversight management to Active Pharmaceutical Ingredient (API) and intermediate contract manufacturing organisations (CMO) engaged by External Manufacturing within a cross functional team.
Key Duties And Responsibilities
- Proactively manage contract manufacturer relationships from a quality and compliance perspective. Build strong effective working relationships with CMO’s
- Develop and manage the quality events, change control and market complaints programs in respect of contract manufacturers. Ensure an effective deviation management system is in place to deal with vendor non-conformances from third party suppliers. Review process validation protocols and reports and also process verification/campaign reports for CMO’s where relevant
- Ensure Quality by Design (QbD) principles are implemented for all new products at CMO’s. Review and approval of process risk assessment, process verification reports for CMO’s for intermediates and API. Support pre-approval inspections
- Manage all activities associated with vendor approvals
- Provide quality/compliance subject matter expertise to the wider Supplier Relationship Management, Global Procurement, Supply Chain and Manufacturing Science & Technology (MS&T) teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs, etc.
- Provide the requisite quality support to Global Bristol Myers Squibb (BMS) functional groups such as Global Regulatory/Chemistry Manufacturing and Controls and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions, etc.
- Manage the quality metrics programs in relation to CMO performance
- Serve as the Quality Operations leader in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties
- Prepare, negotiate and approve Quality Agreements and purchase specs with CMO’s
- Review and approve the Annual Product Reviews submitted by the CMO’s Support the Global BMS external auditing program by participation in audits of Third Parties as requested
- Mange information/provide information for quality council meeting
- Assess and implement corporate policies and directives
- Liaise with auditors of external vendors and suppliers. Review vendor audits to identify trends. Manage audit observation closure
- Review and update CMO Bona Fides as required
- Carry out annual risk assessments for CMOs
- Review and update stability protocols as necessary
- Carry out batch release as required
In the absence of the Associate Director, Quality Operations Global API, the Quality Operations Manager, Global API can act as designee.
- Review and approval of change controls
- Signatory on Good Manufacturing Practices (GMP) documentation
- Representation at meetings
Qualifications, Knowledge And Skills Required
- A Chemical Engineering or Pharmacy background coupled with at least five (5) years of experience in the pharmaceutical sector, ideally focusing on Quality, Manufacturing Technology, Regulatory Affairs, or a role within a Health Authority Agency
- Five years’ experience in the pharmaceutical industry, specifically in API manufacture, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency
- Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables first-hand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences, and interface with research & development
- In-depth knowledge of current Good Manufacturing Practices (cGMP) regulations pertinent to the United States of America (USA), European Union (EU) and other international markets
- Ability to build relationships, partnerships and influence and/or enforce quality decisions at external manufacturers
- Strong negotiation, communication and presentation skills across all levels both internal and external to BMS
- Exhibits BMS BioPharma Behaviors
- Strong analytical and problem solving skills