Senior Qualified Person, Global Pharma Quality

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

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