Job Information
Bristol Myers Squibb Associate Director, Quality Operations Global API in Boudry, Switzerland
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
• 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 quality/compliance subject matter expertise to the wider Supplier Relationship Management, Global Procurement, Supply Chain, QP and MT teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs, market release etc.
• 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
Seven to ten years' experience in the API pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.
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
In depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets
Direct experience interacting with Health Authorities and managing Health Authority inspections, specifically FDA and/or EMA.
Direct experience in interacting with external manufacturers and managing quality at external manufacturing sites.
Ability to assess the right balance between business targets and scientific and quality decisions.
Ability to build relationships, partnerships and influence and/or enforce quality decisions at external manufacturers.
Strong negotiation, communication and presentation skills across all levels both internal and external to BMS.
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.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1586003
Updated: 2024-11-25 03:19:46.136 UTC
Location: Boudry-CH
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.