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Senior Manager, Qualified Person

Bristol Myers Squibb

Dublin, Utrecht
Full-time, Temporary
10+ years experience
Hybrid

Key Skills

Qualified Person
GMP
Pharmaceutical manufacturing
Quality oversight
Batch certification
Regulatory compliance
Risk-based decision making
Stakeholder management
Leadership
Communication
Influencing
Supply chain management
Regulatory affairs
Product launch
Quality operations

Job Description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.


At Bristol Myers Squibb, we are united by a single purpose: transforming patients' lives through science. As part of our Pharma QP Operations organisation, you will play a critical role in ensuring the quality, safety and compliance of medicines supplied to patients across Europe and global markets.

We are seeking an experienced Senior Manager, Qualified Person to join our team on a 12-month fixed-term contract. Reporting to the Director, Pharma QP Operations, this role offers the opportunity to provide independent quality oversight, certify commercial pharmaceutical products and influence strategic quality decisions across a diverse and global manufacturing network.


The Role

As a named EU Qualified Person, you will be responsible for the certification of pharmaceutical products for EU/EEA and Rest of World markets in accordance with GMP, applicable legislation and marketing authorisations. You will work closely with internal manufacturing sites, external manufacturing partners, supply chain, regulatory affairs and quality organisations to ensure uninterrupted supply of compliant medicines to patients.

This 12-month assignment provides a unique opportunity to apply your QP expertise across a complex and global supply network while supporting product launches, strategic business initiatives and continuous improvement within the QP organisation.


Key Responsibilities

  • Perform EU Qualified Person duties in accordance with Directive 2001/83/EC and Annex 16 requirements for EU/EEA and global markets.
  • Provide expert guidance to Quality Operations teams supporting batch certification activities.
  • Support investigations through FIT, FIRM and Product Review Committee processes.
  • Partner with launch excellence, supply chain and manufacturing teams to support new product introductions and market launches.
  • Participate in regulatory inspections, corporate audits, recalls and competent authority notifications.
  • Maintain current knowledge of GMP, regulatory requirements and manufacturing technologies through ongoing professional development.

What You'll Bring

Qualifications

  • EU/EEA QP eligibility meeting the educational requirements of Article 49 of Directive 2001/83/EC.
  • MSc (or equivalent) in a scientific, technical or related discipline.

Experience

  • Significant experience operating in a regulated pharmaceutical manufacturing environment.
  • Demonstrated experience as an actively releasing Qualified Person.
  • Strong knowledge of GMP requirements, pharmaceutical manufacturing processes and regulatory compliance.
  • Proven ability to make independent, risk-based quality decisions and manage complex stakeholder relationships.
  • Strong leadership, communication and influencing skills.

Why Join Bristol Myers Squibb?

This role offers the opportunity to make a meaningful impact on patient supply while working alongside a highly experienced global QP organisation. You'll contribute to the certification and release of innovative medicines, support new product launches and collaborate with manufacturing and quality leaders across the BMS network.

If you're an experienced Qualified Person looking for a challenging 12-month opportunity to apply your expertise in a global organisation dedicated to patients, we'd love to hear from you.


#LI- Hybrid


We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.


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 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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.


Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.


For roles based in Los Angeles County only:  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/


For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.


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.

If this posting is missing required information required by local law or incorrect, contact BMS at [email protected] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.



R1608137 : Senior Manager, Qualified Person

Core Responsibilities

The Senior Manager, Qualified Person is responsible for the certification of pharmaceutical products for EU/EEA and global markets in compliance with GMP and legislative requirements. They will provide expert quality oversight, support investigations, and collaborate with cross-functional teams to ensure the uninterrupted supply of medicines.

Requirements

Candidates must hold EU/EEA Qualified Person eligibility and possess an MSc or equivalent in a scientific or technical discipline. Significant experience in a regulated pharmaceutical manufacturing environment and active experience as a releasing Qualified Person are required.

Benefits

  • Comprehensive benefits
  • Professional development

About Bristol Myers Squibb

Industry: Pharmaceutical Manufacturing

Company size: 10,001+ employees

At Bristol Myers Squibb, we work every day to transform patients’ lives through science. That work inspires some of the most interesting, meaningful, and life-changing careers you’ll experience. Join us and pursue innovative ideas alongside some of the brightest minds in biopharma, collaborating with a team rich in diversity of experiences, and perspectives. We have built a sustainable pipeline of potential therapies and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient, at the right time, to achieve the best outcome. Whether in a scientific, business or supporting function, a career at BMS means you’ll be inspired every day to grow and thrive through opportunities that are uncommon in scale and scope. Here, you’ll be on the cutting edge of powerful innovation in oncology, hematology, immunology, cardiovascular disease, and fibrosis, with colleagues united in the mission to help patients. Through the Bristol Myers Squibb Foundation, we also promote health equity and seek to improve health outcomes of populations disproportionately affected by serious diseases and conditions. Our mission is to give new hope to help patients prevail over serious disease – it drives everything we do. Review our Social Media Community Guidelines at: https://www.bms.com/social-media-community-guidelines.html

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