Manager, Quality Compliance – External Manufacturing

Bristol Myers Squibb

. Provision of Quality Compliance support to the Global Operations teams.

Posted 5/23/2026full-timeDublin • 🇮🇪 IrelandMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Benefits

Comp & perks

wide variety of competitive benefits
resources to pursue goals
balance and flexibility in work environment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality ComplianceQuality AgreementsAnnual Product Review (APQR)Quality Management System (QMS)cGMPGDPRegulatory AffairsQuality ControlQuality AssuranceManufacturing Technology

Soft Skills

analytical skillsproblem-solving skillsrelationship buildinginfluencecommunication skillsorganizational skillsproject management skills

Certifications

BSc in scientific discipline