Manager, External QA
Core
Ensuring external pharmaceutical and medical device partners manufacture, package, analyze, release, store, and distribute products in compliance with regulatory requirements and company policies.
Role type
Senior Specialist Qualified Person (QP) / Product Quality Manager (PQM)
Builds
Non-sterile and sterile pharmaceuticals, medical devices
Domain
Global healthcare, pharmaceutical manufacturing, quality assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global GMP knowledge, risk-based quality oversight, deviation and complaint management, audit coordination, stability program management, process validation, regulatory filing support, supplier quality management, change control, CAPA planning
Preferred skills
Multinational pharma experience, laboratory testing, in-process quality control, external manufacturing management, supply chain operations
Technologies
GMP systems, batch record systems, stability tracking tools
Responsibilities
Evaluate and release products to market or other sites; manage deviations, complaints, and investigations; conduct audits of external manufacturers; oversee repackaging activities; manage stability programs and annual product reviews; provide on-site guidance for quality improvements; monitor partner performance and develop CAPA plans; support process validation and tech transfer; prepare regulatory assessments and document requests; conduct regular site visits.
Seniority
Senior, hands-on IC with leadership responsibilities
