Manager, Quality Operations Drug Product

Job title:

Manager, Quality Operations Drug Product

Company

Bristol-Myers Squibb

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 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: .Bristol Myers Squibb IrelandBristol 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/ieJob Function: Quality Operations Manager, Drug Product, EMEA and Asia PacificResponsibilitiesSupport the coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationshipsActively support the Bristol Myers Squibb (BMS) Fact Finding (FF) and Product Review Committee (PRC) processes for major investigations involving Third Party productsProvide 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 performanceProvide support to Quality Operations Management Team in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third PartiesAssist in the preparation of Quality Agreements with the Third Party Manufacturers and Alliance PartnersReview the Annual Product Reviews submitted by the Third Party ManufacturersSupport the Global BMS external auditing program by participation in audits of Third Parties as requestedProvide support to specified quality and technical projects as they ariseRequired CompetenciesIn depth knowledge of current Good Manufacturing Practices (cGMP) regulations pertinent to the United States of America (USA), European Union (EU) and other international marketsAbility to develop cross-functional and external working relationshipsStrong communication and presentation skills across all levels both internal and external to BMSProven analytical and problem solving skillsRequired Qualification(s) and Desired ExperienceA BSc in a scientific discipline such as Chemistry or MicrobiologyMinimum five (5) years’ experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority AgencyExperience 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 & developmentIdeally will have experience in interacting with Health Authorities and supporting Health Authority inspectionsDirect experience in interfacing with external manufacturersBMS ValuesThe qualified candidate demonstrates characteristics of our BMS Values. For more details refer to myBMS.com and the section Our Values.Why you should applyYou 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.BMSBL#LI-HybridIf 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 ProtocolBMS 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 . Visit 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:Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Expected salary

Location

Dublin

Job date

Fri, 27 Sep 2024 06:39:49 GMT

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