Manager, Quality Operations Drug Product

at  BristolMyers Squibb

Dublin, County Dublin, Ireland -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate26 Dec, 2024Not Specified28 Sep, 2024N/APharmaceutical Industry,Chemistry,Research,Microbiology,ManufacturingNoNo
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Description:

WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Responsibilities:

  • Support the coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships
  • Actively support the Bristol Myers Squibb (BMS) Fact Finding (FF) and Product Review Committee (PRC) processes for major investigations involving Third Party products
  • Provide quality/compliance support to the wider Supplier Relationship Management, Global Procurement, Supply Chain and Manufacturing Technology (MT) teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs, etc.
  • Provide the requisite quality support to Global BMS functional groups such as Global Regulatory/Chemistry, Manufacturing and Controls (CMC) and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions, etc.
  • Coordinate quality metrics programs in relation to Third Party performance
  • Provide support to Quality Operations Management Team in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties
  • Assist in the preparation of Quality Agreements with the Third Party Manufacturers and Alliance Partners
  • Review the Annual Product Reviews submitted by the Third Party Manufacturers
  • Support the Global BMS external auditing program by participation in audits of Third Parties as requested
  • Provide support to specified quality and technical projects as they aris


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

BMS

Proficient

1

Dublin, County Dublin, Ireland