Manager, Quality Services, External Manufacturing
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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. 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 at 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 on a Fixed Term Contract.
Manager, Quality Services, External Manufacturing, reporting to Associate Director Quality Compliance, ExM Quality A&I External Manufacturing.
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.
Key Duties And Responsibilities
Provide quality/compliance support to the Quality Operations.
Co-ordinate/track the annual CMO Risk Assessment (RA), ensuring timely completion of the assessment.
Support Quality Risk Mitigation Plans for CMOs based on the annual RA and any other interim triggers, and monitor their implementation.
Write, revise and review GMP documentation where necessary.
Prepare / negotiate Quality Agreements with the Third Party Manufacturers, Third Party Customers (TPCs), Alliance Partners and Marketing Authorisation Holders, including those associated with multiple CMOs / BMS parties.
Support the Quality Operations metrics programs in relation to both Third Party and External Manufacturing performance.
Support receipt of the Annual Product Quality Reviews (APQRs) from the Third Party Manufacturers and manage Quality Operations compliance with the APQR procedure.
Work with BMS sites to ensure that APQRs are provided to TPCs and Alliance Partners in a timely manner.
Support gap analysis of site SOPs / quality directives / policies / global Health Authority (HA) observations as the SME for Quality Operations and ensure gaps are mitigated.
Where applicable lead/support the Quality Council activities.
Provide general GMP / GDP HA inspection or Self Inspection support as required (preparation, back room, etc.).
Manage the quality oversight for TPCs / Alliance partners including change management, complaint management and investigation and CAPA management.
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, and regulatory agency questions etc. for CMOs.
Represent ExM Quality on global quality teams/initiatives/projects and lead projects as needed.
Assist the exchange of regulatory information required for filing updates or HA renewal for products supplied to TPCs and Alliance Partners.
Where applicable support the BMS Fact Finding Information Team (FIT) and Fact Finding Information Review Meeting (FIRM) processes and support the Product Review Committee (PRC) process for major investigations involving third Party Active Pharmaceutical Ingredients (API) and Drug Products. Prepare and present the information to senior management in support of the FIT / FIRM processes.
Where applicable support the Product Action Committee (PAC) process for all recalls associated with Contract Manufacturing Organizations (CMOs) managed by ExM.
Qualifications, Knowledge and Skills Required
BSc or equivalent in scientific discipline.
Greater than seven (7) years' experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, or Regulatory areas, 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.
Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically FDA and/or EMA.
Direct experience in interacting with external manufacturers and supporting quality at external manufacturing sites.
In depth knowledge of cGMP / GDP regulations pertinent to the USA, EU and other international markets.
Ability to assess the right balance between business targets and scientific and quality decisions.
Strong analytical and problem solving skills.
Ability to build relationships, partnerships and influence and/ or enforce quality decisions at external / internal sites as appropriate.
Good communication and organizational skills.
Project management skills.
Occasional travel may be required as part of this role.
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.
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 a supportive culture, promoting global participation 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 an 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/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.
Additional Information
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/.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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