Senior Manager, CSCQ, Qualified Person

Bristol Myers Squibb; Dublin; On-site; EUR 50,000 - 70,000; Full time

Job summary

A global biopharmaceutical company based in Dublin is seeking a Quality professional to oversee supply chain quality activities, including EU Qualified Person certification and regulatory compliance. This role requires a science degree and experience in quality assurance. A competitive salary and multiple benefits are offered, including 27 days of annual leave and an annual bonus.

Benefits

Annual bonus

Pension contribution

Family health insurance

On-site gym

27 days of annual leave

Qualifications

• University degree (science degree preferred).
• Eligibility to act as an EU Qualified Person.
• Experience as a Qualified Person desirable.

Responsibilities

• Support start-up activities for Clinical Supply Chain Quality.
• Review and approval of QA/QP related procedures.
• Qualified Person release of IMP's in accordance with BMS procedures.

Skills

Experience in communicating with regulatory authorities

Ability to make significant quality decisions

Education

University degree (science degree preferred)

Eligibility to act as an EU Qualified Person

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. 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 .

The Role

This is a position within the Global Product Supply (GPS) Pharma Product Development (PD) Quality organisation that is responsible for the oversight of CSC Quality activities including CSC Logistics EMEA/ASIA PAC operations. The position is responsible for EU Qualified Person (QP) certification and release activities for supply to clinical trials, audit of internal GMP systems/processes and suppliers/third party contractors, as well as assisting stakeholders with regulatory advice and preparation for and management of regulatory agency inspections. This position provides support for the identification and resolution of critical quality issues that may affect BMS.

This is a 12 month fixed term contract role.

Key Duties and Responsibilities:

• Support start-up activities for Clinical Supply Chain Quality Dublin, including but not limited to:
• Review and approval of QA/QP related procedures
• Support preparation and approval of training materials
• Support review and approval of Quality Agreements
• Ensure knowledge transfer from current release site
• Support Manufacturer(s)/Importation Authorisation submissions as required
• Support sustaining operations, including but not limited to:
• Qualified Person release of IMP's in accordance with BMS procedures and regulatory requirements
• Provide support to Health Authority GMP/GDP inspections and audits across the supply chain
• Advise stakeholders on quality issue management and process enhancement/compliance, ensuring consistent quality standards and fostering strong working relationships
• Incorporate global regulatory trends and changes into Supply Chain Quality.
• Support Site Master File maintenance
• Oversee Manufacturer(s)/Importation Authorisation update and maintenance
• Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products to business partners and senior management
• Review and approve procedural documents
• Participate in multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline
• Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level
• May influence the external environment through interactions with regulators, trade associations, or professional societies
• Proactively identify risk areas
• Provide input in the global audit plans based on identified signals/trends/risks/gaps
• Supervise QA personnel as assigned
• Undergo continuous professional development including self-study, site visits, internal and external training courses and audits
• Support OPEX programs and champion continuous quality improvement initiatives and other efficiency initiatives

Qualifications, Knowledge and Skills Required:

Education/Experience/ Licenses/Certifications:

• Education/Experience/ Licenses/Certifications: University degree (science degree preferred).
• Eligibility to act as an EU Qualified Person i.e. either an EU Pharmacy degree or other equivalent qualification.
• Experience as a Qualified Person desirable.
• Experience in communicating with regulatory authorities and making significant quality decisions

Travel:

This position requires up to 10% of travel

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 of annual leave , access to BMS Cruiserath on-site gym and life assurance

#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 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.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and 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 [e-mail] . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

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: R1596706

Updated: 2025-11-28 04:50:28.634 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.