Senior Manager, Qualified Person

Bristol-Myers Squibb; Dublin; Hybrid; EUR 120,000 - 150,000; Full time

Job summary

Bristol Myers Squibb in Ireland is seeking an experienced Senior Manager, Qualified Person to join our Pharma QP Operations on a 12-month fixed-term contract. As a named EU Qualified Person, you will certify pharmaceutical products for EU/EEA and global markets in compliance with GMP.

You will collaborate with internal sites, external manufacturers, regulatory affairs and quality teams to ensure uninterrupted supply of compliant medicines to patients, support product launches and drive

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.

Responsibilities

• Perform EU Qualified Person duties for EU/EEA and global markets in accordance with GMP and regulatory requirements.
• 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 and regulatory notifications, recalls and audits.
• Maintain current knowledge of GMP and regulatory requirements through ongoing professional development.

Skills

EU/EEA QP eligibility

MSc in science/related

Education

MSc in scientific/technical discipline

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.

#LI- Hybrid

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

Candidate Rights

BMS will consider q