Lead and manage the Quality department, including hiring, training, and performance management
Ensure compliance with cGMP, FDA, EMA, ISO 13485 and other global regulatory requirements
Oversee quality systems including CAPA, deviations, change control, and document management
Function as the primary quality interface with CDMOs and testing labs.
Drive inspection readiness and lead internal audits
Review and approve batch records, SOPs, change controls, methods, specifications, protocols and reports, and quality-related documentation
Collaborate with cross-functional teams to support product development and commercialization
Manage supplier quality and oversee vendor qualification processes
Identify and implement continuous improvement initiatives within the quality system
Monitor key quality metrics and report trends to senior leadership
Ensure proper investigation and resolution of quality issues and complaints

Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field (advanced degree preferred)
8–12+ years of experience in pharmaceutical/biotech QA roles, with leadership responsibility
Strong knowledge of cGMP regulations and global regulatory requirements
Proven hands-on experience managing quality systems (batch review, CAPA, deviations, change control)
Strong analytical and problem-solving abilities
Ability to travel up to 10–20% as needed

Senior Quality Manager

Key skills