Senior Manager, Quality Services, ExM Bio/Sterile

Job title:

Senior Manager, Quality Services, ExM Bio/Sterile

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/ieThe RoleBMS External Manufacturing is looking to recruit a fix term Senior Manager, Quality Services, ExM Bio/Sterile who will provide quality services and compliance support to Quality Operations in External Manufacturing Quality, ensure that appropriate Bristol Myers Squibb (BMS) Good Manufacturing Practices (GMP) and regulatory standards are adhered to for products supplied by BMS sites and Contract Manufacturing Organisations (CMOs) through External Manufacturing.Key Responsibilities

• Lead Site Quality Council and support GxP /Pillar Quality Council to ensure Quality Operations metrics are available from BMS Systems and the CMOs; Health Authority (HA) Inspection Tracking, Market Action Status, Significant Event Monitoring, deviation closure, etc.
• Drive attainment of the Quality Operations KPI metrics and performance improvement
• Raise Notifications to Management (NTMs) where required for major and critical investigations.
• Lead 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 BioSterile manufacture. Prepare and present the information to senior management in support of the FIT / FIRM processes.
• Support the Product Action Committee (PAC) process for all recalls associated with CMOs managed by ExM.
• Support issuance of HA notifications (e.g. Field Alert Reports) where required.
• Lead Global Regulatory Observation evaluation (GROe) Assessments on behalf of ExM BioSterile.
• Provide quality/compliance support to the Quality Operations Managers
• Lead Continuous Improvement and/or Compliance projects supporting the External Manufacturing (ExM) or network.
• Coordinate/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.
• Management of the Quality Agreement process.
• Drive adherence to Annual Quality Agreement Plan for TPMs, Third Party Customers (TPCs), Alliance Partners and Marketing Authorisation Holders (MAHs), including those associated with multiple CMOs / BMS parties.
• Prepare / negotiate Quality Agreements with the CMOs, internal sites and MAHs, including those associated with multiple CMOs / BMS parties.
• Manage the quality oversight for TPCs / Alliance partners & Build strong effective working relationships with TPCs and Alliance Partners.
• Support receipt of the Annual Product Quality Reviews (APQRs) from the CMOs – drive Quality Operations compliance with the APQR procedure.
• Support gap analysis of site standard operating procedures (SOPs) / quality directives / policies / global Health Authority (HA) observations as the Subject Matter Expert (SME) for Quality Operations Europe, the Middle East and Africa (EMEA) and ensure gaps are mitigated.
• Represent the tower during HA inspections including inspection preparations.
• Provide general GMP / Good Distribution Practice (GDP) HA inspection or Self-Inspection support as required (preparation, back room, etc.).
• Support the bona fide process as required.
• Represent ExM BioSterile business unit on global quality teams/initiatives/projects and lead projects as needed.
• Write, revise and review GMP documentation where necessary.

Required competencies

• In depth knowledge of current Good Manufacturing Practices (cGMP) / GDP regulations pertinent to the United States of America (USA), European Union (EU) and other international markets.
• Ability to assess the right balance between business targets and scientific and quality decisions.
• Operational Excellence and Project Management skills.
• Information technology (IT) systems knowledge and ability to extract and analyse data from multiple sources.
• Strong analytical, problem solving and problem-solving skills.
• Ability to build relationships, partnerships and influence and/ or enforce quality decisions at external / internal sites as appropriate.

Required Qualifications and desired experience

• Equivalent to 8 years’ experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, or Regulatory areas, or a position within a health Authority agency.
• Bachelor of Science (BSc) or equivalent in scientific discipline.
• 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 the Food and Drug Administration (FDA) and/or European Medicines Agency (EMA).
• Direct experience in interacting with external manufacturers and supporting quality at external manufacturing sites.

Note: Occasional travel may be required as part of this roleWhy 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 of annual leave , access to BMS Cruiserath on-site gym and life assurance.

#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

Sat, 16 Nov 2024 01:19:44 GMT

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