Senior Product Quality Manager (Peptide Technology)
Core
Lead quality deliverables for late-stage development and commercialization of Peptides, ensuring compliance with regulations and supporting the end-to-end commercial supply chain.
Role type
Senior Product Quality Manager (Peptide Technology)
Builds
Global Product Quality Assurance strategy for New Product Introduction (NPI) programs
Domain
Pharmaceutical manufacturing (Peptides)
Deliverable
client delivery
Required skills
Peptide manufacturing development, Quality Assurance Operations Management, FDA and regulatory agency interactions, GMP manufacturing site coordination, external manufacturing partner qualification, Corrective and Preventive Actions (CAPA), root cause analysis, regulatory submission module 3 documents
Preferred skills
Direct Manufacturing Plant experience in pharmaceutical setting, pharmaceutical development and commercialization experience
Technologies
GMP, NPI, Module 3 documents
Responsibilities
Lead development and implementation of global Product Quality Assurance strategy for NPI programs; Drive implementation of the Product Transfer Process; Act as global quality lead to support regulatory submissions; Lead pre-approval inspection readiness; Lead selection and qualification of external manufacturing partners; Support management of exception documents and CAPA; Serve as global quality representative at change review boards.
Seniority
Senior, hands-on IC