Job Description:
Latest job information from Jobtailor for the position of Manager, Quality Compliance – External Manufacturing. If the Manager, Quality Compliance – External Manufacturing vacancy in Dublin matches your qualifications, please submit your latest application or CV directly through the updated Jobkos job portal.
Please note that applying for a job may not always be easy, as new candidates must meet certain qualifications and requirements set by the company. We hope the career opportunity at Jobtailor for the position of Manager, Quality Compliance – External Manufacturing below matches your qualifications.
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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Job Info:
- Company: Jobtailor
- Position: Manager, Quality Compliance – External Manufacturing
- Work Location: Dublin
- Country: IE
How to Submit an Application:
After reading and understanding the criteria and minimum qualification requirements explained in the job information Manager, Quality Compliance – External Manufacturing at the office Dublin above, immediately complete the job application files such as a job application letter, CV, photocopy of diploma, transcript, and other supplements as explained above. Submit via the Next Page link below.
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