Senior Manager, EU Qualified Person - 12-Month Contract

Bristol-Myers Squibb Co

Dublin

Presencial

EUR 140.000 - 180.000

Jornada completa

Hace 7 días
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Descripción de la vacante

Bristol Myers Squibb is seeking an experienced Senior Manager, Qualified Person to join our Pharma QP Operations. You will certify pharmaceutical products for EU/EEA and Rest of World markets, ensuring GMP compliance and regulatory submissions while collaborating with internal sites, external partners, and quality teams.

This 12-month assignment offers leadership opportunities, exposure to global launches, and a role focused on independent quality oversight and compliant product release.

Formación

  • EU/EEA QP eligibility per Directive 2001/83/EC.
  • MSc (or equivalent) in a scientific/technical discipline.
  • Significant experience in a regulated pharmaceutical manufacturing environment.
  • Proven ability to make independent, risk-based quality decisions and manage complex stakeholder relationships.

Responsabilidades

  • Perform EU Qualified Person duties per Directive 2001/83/EC for EU/EEA and global markets.
  • Provide guidance to Quality Operations teams supporting batch certification.
  • Support investigations through FIT, FIRM and Product Review Committee processes.
  • Partner with launch excellence, supply chain and manufacturing teams for 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.

Conocimientos

QP eligibility
Regulated pharma
Quality decision making
Leadership
Stakeholder management
Communication

Educación

MSc in science/tech
EU/EEA QP eligibility

Descripción del empleo

Bristol Myers Squibb is seeking an experienced Senior Manager, Qualified Person to join our Pharma QP Operations. You will certify pharmaceutical products for EU/EEA and Rest of World markets, ensuring GMP compliance and regulatory submissions while collaborating with internal sites, external partners, and quality teams.

This 12-month assignment offers leadership opportunities, exposure to global launches, and a role focused on independent quality oversight and compliant product release.

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