Dublin, IE
1 day ago
Manager, Clinical Supply Chain Quality

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

Bristol-Myers Squibb Services Unlimited are responsible for Clinical Supply Chain Quality including Certification and Sponsorship of new and in-flight clinical trials destined for Europe and beyond.

Clinical Supply Quality is seeking to recruit on a permanent contract a Manager, Clinical Supply Chain Quality, to support activities. Reporting to the Director of Clinical Supply Quality, the Manager will provide QA support to Qualified Person (QP) for Investigation Medicinal Product (IMP) supplies shipped through the EU Central Warehouse (EUWH) and provide QA support and oversight to Clinical Supply Logistics.

Key Duties and Responsibilities:

Compilation and review of batch release dossiers for Qualified Person certification of IMP to clinical trials.Updates and maintains the site Manufacturing and Importation Authorisation (MIA) in accordance with regulatory requirements and maintains the Site Master File.Generates and maintains Product Specification Files (PSF) for IMP.Provides QA support and oversight of packaging and labeling operations for IMP.Support the generation and ongoing maintenance of Quality Agreements.Provides Quality Assurance support in the Use Date Extension process.Provides Quality Assurance oversight and support (GMP/GDP guidance and training) for CSO Logistics (EMEA and Asia)Supports in a timely manner, investigations of non-conformances and quality incidents as QA. Resolves and documents in the Quality Management System.Conducts appropriate follow-up, as required. Tracks deviation, investigations and CAPAs;Generate and complete QA review of supplier/customer qualification documentation for the Responsible Person (RP). Ensure supplier/customer qualification and re-qualification is complete within required timelines.Provide support to Health Authority inspections and internal audits as required.Prepares and reviews procedural documents.Complete Change control assessment and CAPA evaluation/CAPA close-outInterface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.Support OPEX programs and champion continuous quality improvement initiatives.

Qualifications, Knowledge and Skills Required:

The successful candidate will hold a BSc in Science or related discipline, with relevant QA or related experience in a Pharmaceutical environment.The candidate should hold a minimum of 3 years experience in a GMP/GDP environment.A clear understanding of cGMP and GDP requirements for the manufacture and distribution of medicinal products.The candidate should also be open to travel (up to 10%) in support of their role.The Manager will be required to work on his/her own initiative in addition to working as part of a team.The candidate must be able to work across a team matrix in order to meet accelerated timelines. Excellent communication, presentation and critical thinking skills are essential.The successful candidate must demonstrate excellent time management & organisational skills along with a proven ability to multi-task.

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.

BMSBL

#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

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/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.

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