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, Qualified Person (QP)
Builds
Certified pharmaceutical products for patient supply
Domain
Pharmaceutical manufacturing / Regulatory compliance
Deliverable
physical/clinical work
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
Technologies
GMP, Directive 2001/83/EC, Annex 16
Responsibilities
Perform EU Qualified Person duties for EU/EEA and global markets, provide expert guidance on batch certification, support investigations through FIT/FIRM/Product Review Committee processes, partner with launch/supply chain/manufacturing teams for new product introductions, participate in regulatory inspections/audits/recalls, maintain current knowledge of GMP and manufacturing technologies
Seniority
Senior Manager, fixed-term contract
