Associate Director, Quality Operations Global Api
vor 3 Monaten
**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.
**Responsibilities**:
- To lead the quality and compliance oversight management of third party manufacturers engaged by External Manufacturing within a cross functional team.
- To ensure that the Quality resources working on priority Virtual Plant Teams (VPTs), or multiple VPTs are appropriate, effective and coordinated.
- For specified products, lead a team to support the release activities in accordance with the conditions of our manufacturing authorization and provide strategic oversight on the API release process.
- Proactively manage contract manufacturer relationships from a quality and compliance perspective.
- Develop and manage the quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships.
- Review process validation protocols and reports and also process verification/campaign reported for CMO's where relevant.
- Review and approval of process risk assessment, process verification reports for CMO's for intermediates and API. Support pre-approval inspections
- Manage all activities associated with vendor approvals.
- Actively support the BMS Fact Finding Investigations (FIT) and Product Review Committee (PRC) processes for major investigations involving Third Party products. Prepare and present the information to senior management in support of the FIT/PRC processes.
- Provide the requisite quality support to Global BMS functional groups such as Global Regulatory/CMC and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions etc.
- Manage the quality metrics programs in relation to CMO performance.
- Serve as the Quality Operations leader in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties.
- Prepare, negotiate and approve Quality Agreements and purchase specs with CMO's
- Review and approve the Annual Product Reviews submitted by the CMO's Support the Global BMS external auditing program by participation in audits of Third Parties as requested.
- Manage information/provide information for quality council meeting.
- Assess and implement corporate policies and directives
- Select and retain Quality employees on VPTs
- Allocate resources such that the right person is doing the right work at the right time
- Review and approve goals and objectives for direct reports
- Proactively develop and mentor staff
Required Competencies
1. Seven to ten years' experience in the API pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.
2. Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables first-hand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
3. In depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets
4. Direct experience interacting with Health Authorities and managing Health Authority inspections, specifically FDA and/or EMA.
5. Direct experience in interacting with external manufacturers and managing quality at external manufacturing sites.
6. Ability to assess the right balance between business targets and scientific and quality decisions.
7. Ability to build relationships, partnerships and influence and/or enforce quality decisions at external manufacturers.
8. Strong negotiation, communication and presentation skills across all levels both internal and external to BMS.
9. Strong analytical and problem solving skills.
Required Qualification(s) and Desired Experience
Minimum a BSc, preferably with a postgraduate qualification and minimum 7 years' experience in a GMP manufacturing environment. OpEx experience desirable.
**Uniquely Interesting Work, Life-changing Careers**
**On-site Protocol**
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at l
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