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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 on a permanent Contract Manager, Clinical Supply Chain Quality , reporting to Director, Clinical Supply Chain, QP.

The Role

PDQ Good Manufacturing Practice (GMP) serves as the Quality Assurance Unit overseeing manufacture, testing and distribution of clinical supplies (investigational products) to assure quality and compliance with Good Manufacturing Practices (GMP) and other applicable regulations and internal procedures.

Key responsibilities include: supporting drug substance and drug product batch disposition (release/reject decision), product certification and release by the EU Qualified Person, preparation of product specification files and supply chain flow maps, maintenance of the clinical supply chain quality management system as well as assist stakeholders with regulatory advice and preparation for and management of regulatory agency inspections.

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:

• Compiles Qualified Person batch release dossiers

• Supports Packaging & Labeling activities performed at EUWH.

• Provides Quality Assurance support in the Use Date Extension process.

• Provides Quality Assurance support (GMP/GDP guidance and training) for CSO Regional Logistics.

• Support in a timely manner, the investigations of non-conformances and quality incidents. Resolves and documents into Quality Management System deviations or problems pertaining to the review of documents. Conducts appropriate follow-up as required. Tracks deviation, investigations and CAPAs.

• Authors ISR related Quality agreements, keeps agreements current and manages updates required.

• Prepares release dossiers for ISRs

• Prepares and reviews procedural documents as requested by supervisor.

• Support preparation of training materials.

• Contribute to improving and maintaining CSCQ QMS

• Prepare and approve supply chain flow maps, and product specification files.

• Authoring, review, and approval of QA-related procedures

• Supporting generation of/updates existing Quality Agreements.

• Adherence to BMS core behaviors

• (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Qualifications, Knowledge and Skills Required:

• Science, engineering or Pharmacy degree or similar required.

• At least 3 years' experience, 5 years' experience preferred, in biopharmaceutical/pharmaceutical industry.

• Experience in Pharmaceutical Industry Quality function a preference

• Experience in EU release of Pharmaceutical or Biopharmaceuticals a preference

• Strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance

• Proven ability to learn quickly and keep up to speed in fast paced work environment.

• Proven clear communication supporting delivery for the business.

• Proven ability to continually work to improve services, and work processes.

• Proven ability to contribute as part of a team.

• Proven ability to influence others.

• Proven ability to work under pressure

• Travel may be required for this position and is anticipated to be approximately 10% of the time.

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/ (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.

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.

Company: Bristol-Myers Squibb

Req Number: R1585103

Updated: 2024-09-18 05:50:43.751 UTC

Location: Dublin-IE

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.