Manager, Quality Compliance – External Manufacturing

Responsibilities

• Provision of Quality Compliance support to the Global Operations teams.
• Oversight of Alliance Partners and Third-Party Customers.
• Preparation and oversight of Quality Agreements.
• Support for the Annual Product Review (APQR) process.
• Support for ExM, Enterprise and GBU Quality Council processes.
• Generation, compilation and reporting of metric data to support Global Quality Metric reporting.
• Support preparation, revision, and maintenance of Quality Agreements with CMOs, internal BMS sites, Third Party Customers, and Alliance Partners.
• Provide day‑to‑day Quality Services support to ExM Operations, including APQR coordination, Quality Agreement activities, and handling quality compliance queries.
• Support compliance tracking activities across the GBU.
• Support ExM, Enterprise, and GBU Quality Council activities by preparing inputs, ensuring metrics availability, and tracking action items.
• Assist in maintaining Quality Services systems (e.g., APQR, Quality Agreements, Quality Council processes) in alignment with procedures and training.
• Support management of relationships with Third Party Customers and Alliance Partners and coordinate quality‑related communications such as deviations, change controls, and complaint responses.
• Support Regulatory, CMC, Supply Chain, and other cross‑functional partners on filings, renewals, investigations, and product lifecycle activities.
• Compile and report Quality Services metrics and trend data and support continuous improvement activities related to QMS performance.
• Review or assist with review of QMS as assigned and support network‑wide continuous improvement initiatives impacting QMS effectiveness, including contributing to GROe assessments.
• Serve as Local Process Owner, as required, with responsibility for assigned Quality Systems (e.g., APQR, Quality Council, Quality Agreements), ensuring procedures, training, metrics, and compliance are maintained.

Requirements

• BSc or equivalent in scientific discipline
• Greater than five (5) years’ experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, or Regulatory areas, or a position within a Health Authority agency
• Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations, including manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
• Direct experience interacting with Health Authorities and supporting inspections, specifically FDA and/or EMA
• Direct experience interacting with external manufacturers and supporting quality at external manufacturing sites
• In‑depth knowledge of cGMP / GDP regulations pertinent to the USA, EU and other international markets
• Ability to assess the right balance between business targets and scientific and quality decisions
• Strong analytical and problem‑solving skills
• Ability to build relationships, partnerships and influence and/or enforce quality decisions at external and internal sites as appropriate
• Good communication and organisational skills
• Project management skills

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