Senior Manager, Qualified Person

Biopharma Careers; Dublin; On-site; EUR 90,000 - 150,000; Full time

Job summary

Bristol Myers Squibb is seeking an experienced Senior Manager, Qualified Person for a 12-month fixed-term contract. You will certify pharmaceutical products for EU/EEA and Rest of World markets, working with internal sites, external partners, regulatory affairs and quality teams to ensure uninterrupted supply of compliant medicines.

As a named EU Qualified Person, you will oversee product release and support strategic quality decisions across a global manufacturing network, contributing to

Qualifications

• 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.

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.

Skills

Regulated manufacturing

Active releasing QP

GMP knowledge

Regulatory compliance

Leadership & communication

Education

EU/EEA QP eligibility per Article 49

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.

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.

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.

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 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 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.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail]. Please provide the Job Title and Requisition number so we can review.

R1605572 : Senior Manager, Qualified Person