Quality Control Director
Core
Leading Quality Control laboratory operations to ensure GMP compliance, support commercial manufacturing, and manage new product introductions across the validation lifecycle.
Role type
Director of Quality Control (GMP)
Builds
High-quality medicines and vaccines for patients
Domain
Biopharmaceuticals / Vaccines / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP laboratory operations, regulatory inspection readiness, method transfer and assay qualification, organizational leadership, cross-functional partnership, data integrity (ALCOA), validation activities
Preferred skills
Master's or PhD in scientific discipline, new product introduction experience, digital laboratory systems and automation
Technologies
Robotics, digital solutions, artificial intelligence, digital laboratory systems, automation, data/reporting tools
Responsibilities
Lead and oversee Quality Control laboratory operations supporting GMP testing, release, and stability programs; Ensure laboratories are inspection-ready and operate in compliance with regulatory and quality system requirements; Provide leadership for QC readiness activities related to new product introductions, technology transfers, and lifecycle changes; Oversee method transfer and assay qualification activities in alignment with technical and regulatory requirements; Ensure effective QC organizational readiness, including staffing, training, onboarding, and capability development; Support QC involvement in commissioning, qualification, and validation activities for laboratory facilities, equipment, and systems
Seniority
Director, strategic leadership & operational oversight
