EM&S Vaccines Quality Lead - Person in Plant
Core
Primary Quality representative for Contract Manufacturing Organizations (CMOs) ensuring end-to-end quality oversight and compliance with cGMP standards for vaccine manufacturing.
Role type
Quality Lead (Person-in-Plant) for Contract Manufacturing
Builds
Safe, high-quality vaccines via external CMOs
Domain
Biopharmaceutical manufacturing (Vaccines)
Deliverable
client delivery
Required skills
cGMP knowledge, Quality Management Systems, deviation management, CAPA, change control, validation, investigations, quality risk management, regulatory compliance, stakeholder management, negotiation, problem-solving, decision-making
Preferred skills
People leadership, matrix organization navigation
Technologies
None stated
Responsibilities
Review and approve GMP documentation (batch records, deviations, CAPAs, change controls, validation, investigations, PQRs, technical specs); Monitor quality performance via KPIs and drive remediation; Support internal, supplier, and regulatory audits; Lead preparation and negotiation of Quality Agreements; Represent Quality in governance meetings and cross-functional teams
Seniority
Senior, hands-on IC with people leadership