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Senior Specialist, Quality Compliance Global API
Client: Bristol Myers Squibb
Location: Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: e1634d1764dc
Job Views: 113
Posted: 03.03.2025
Expiry Date: 17.04.2025
Job 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 Ireland
Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units. Ireland is home to External manufacturing’s global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO’s) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network. This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites.
The Role
Bristol Myers Squibb is looking to recruit on a Fixed Term Contract, Senior Specialist, Quality Compliance Global API to manage compliance and regulatory requirements for Global API Quality Operations group in External Manufacturing Quality.
Key Duties and Responsibilities:
* Manage / track the API Quality Agreement program to ensure regulatory compliance
* Engage with internal and external stakeholders to prepare, negotiate and organise approval of Quality Agreements with Internal Sites
* Manage the BMS Fact Finding (FF) process for major investigations involving Global API Contract Manufacturing Organisations (CMOs) & products
* Manage compliance program for Global API quality group
* Manage/track the annual CMO Risk Assessment process
* Manage the Global API Quality Operations metrics programs in relation to CMO performance
* Compile and deliver the monthly Tier 3B Quality Council in line with site procedures
* Manage / track compliance of Global API CMO’s to Wholesale Distribution Authorisation (WDA)
* Work with quality operations managers to manage Quality Operations compliance to the Annual Product Quality Review (APQR) procedure
* Develop, and update standard operating procedures (SOPs), Work Instructions as applicable
* Manage gap analysis of site SOPs
* Provide Good Manufacturing Practice (GMP) Health Authority inspection support
* Review new regulatory and emerging guidelines to assess impact to External Manufacturing operations
* Manage/track the progression and close out of Regulatory actions associated with External Manufacturing Change Controls
* Track the progression and close out of Deviations / Corrective Actions and/or Preventive Actions (CAPAs)
* Manage Regulatory documentation request to support filings, updates, renewals and HA requests
* Act as API representative for compliance related topics on cross functional teams
* Work with the Virtual Plant Teams (VPTs) to manage and track the stability programme at CMOs
* Carry out batch release as required
Qualifications, Knowledge and Skills Required:
* Greater than two years’ experience in the pharmaceutical industry
* Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations
* In depth knowledge of current Good Manufacturing Practices (cGMP) regulations
* Direct experience interacting with Health Authorities
* Ability to assess the right balance between business targets and scientific and quality decisions
* Strong analytical and problem solving skills
* Strong project management and organizational skills
* The ideal candidate should hold a chemistry, chemical engineering or Pharmacy qualification
Why you should apply
* You will help patients in their fight against serious diseases
* You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
* You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.
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