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Manager, Quality Operations
Manager, Quality Operations-September 2024
Dublin
Sep 19, 2024
ABOUT BRISTOL MYERS SQUIBB
Bristol Myers Squibb is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases.
10,000+ employees
Biotechnology, Healthcare
VIEW COMPANY PROFILE >>
About Manager, Quality Operations

  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 .

  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. In Ireland, External Manufacturing has two sites; Global Headquarters based in Dublin 15 and a distribution centre in Shannon, Co Clare.

  For more information about Bristol Myers Squibb, visit us at BMS.com/ie

  The Role:

  BMS External Manufacturing is looking to recruit a for a permanent Manager, Quality Operations within Global Quality External Manufacturing.

  The Quality Operations Manager can act as designee for Quality Operations Senior Manager.

  Key Duties and 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 arise

  Qualifications, Knowledge and Skills Required:

  In depth knowledge of current Good Manufacturing Practices (cGMP) regulations pertinent to the United States of America (USA), European Union (EU) and other international markets

  Ability to develop cross-functional and external working relationships

  Strong communication and presentation skills across all levels both internal and external to BMS

  Proven analytical and problem-solving skills

  A BSc in a scientific discipline such as Chemistry or Microbiology

  Minimum five (5) years’ experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency

  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

  Ideally will have experience in interacting with Health Authorities and supporting Health Authority inspections

  Direct experience in interfacing with external manufacturers

  What’s important to us:

  Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:

  Passion : Our dedication to learning and excellence helps us to deliver exceptional results.

  Innovation : We pursue disruptive and bold solutions for patients.

  Urgency : We move together with speed and quality because patients are waiting.

  Accountability : We all own BMS’ success and strive to be transparent and deliver on our commitments.

  Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.

  Inclusion : We embrace diversity and foster an environment where we can all work together at our full potential.

  We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.

  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, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.

  Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.

  #LI-Hybrid

  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

  Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

  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 [email protected] . 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.

  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: R1577810

  Updated: 2024-01-23 09:05:26.261 UTC

  Location: Dublin,Ireland

  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.

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