Senior Manager, Qualified Person
Core
Independent quality oversight and certification of commercial pharmaceutical products for EU/EEA and global markets in accordance with GMP and applicable legislation.
Role type
Senior Manager, EU Qualified Person (QP)
Builds
Certified pharmaceutical products for patient supply across Europe and global markets
Domain
Pharmaceutical manufacturing and regulatory compliance
Required skills
EU/EEA QP eligibility, MSc in scientific/technical discipline, GMP knowledge, pharmaceutical manufacturing processes, regulatory compliance, risk-based quality decision making, stakeholder management
Preferred skills
Leadership, communication, influencing skills, experience with new product introductions and market launches
Technologies
GMP, Directive 2001/83/EC, Annex 16, FIT, FIRM, Product Review Committee
Responsibilities
Perform EU Qualified Person duties for EU/EEA and global markets; Provide expert guidance to Quality Operations teams on 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; Participate in regulatory inspections, corporate audits, recalls and competent authority notifications; Maintain current knowledge of GMP and regulatory requirements through professional development
Seniority
Senior Manager, hands-on IC with strategic influence
