Senior Manager, EU Qualified Person

Bristol Myers Squibb; Dublin; On-site; EUR 100,000 - 140,000; Full time

Job summary

Bristol Myers Squibb in Ireland is seeking an experienced Senior Manager, Qualified Person to join our Pharma QP Operations team on a 12-month fixed-term contract. You will provide independent quality oversight, certify commercial pharmaceutical products and influence strategic quality decisions across a global manufacturing network.

As a named EU Qualified Person, you will certify products for EU/EEA and Rest of World markets in accordance with GMP, applicable legislation and marketing

Qualifications

• EU/EEA QP eligibility required.
• MSc (or equivalent) in a scientific/technical discipline required.
• Significant experience in a regulated pharmaceutical manufacturing environment.
• Proven track record as an actively releasing Qualified Person.
• Strong knowledge of GMP and regulatory compliance.
• Ability to make independent, risk-based quality decisions and manage complex stakeholder relationships.

Responsibilities

• Perform EU Qualified Person duties in accordance with Directive 2001/83/EC and Annex 16 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 and regulatory requirements.

Skills

Leadership

GMP knowledge

Regulatory compliance

Stakeholder management

Communication

Education

EU/EEA QP eligibility

MSc (or equivalent) in a scientific/technical discipline

Job description

Bristol Myers Squibb in Ireland is seeking an experienced Senior Manager, Qualified Person to join our Pharma QP Operations team on a 12-month fixed-term contract. You will provide independent quality oversight, certify commercial pharmaceutical products and influence strategic quality decisions across a global manufacturing network.

As a named EU Qualified Person, you will certify products for EU/EEA and Rest of World markets in accordance with GMP, applicable legislation and marketing