We are seeking a Senior Manager, GMP Quality Assurance to support and continuously improve Quality Systems across clinical and commercial products. This role provides leadership across internal teams and external partners to ensure compliance with global GMP/GDP regulations and company standards.Key ResponsibilitiesLead batch release activities, including review/approval of batch records and material dispositionProvide GMP oversight for manufacturing and distribution partners (DS, DP, and supply chain)Ensure compliance with global regulations (FDA, EMA, ICH)Manage investigations, deviations, CAPA, and change controlsSupport audits, inspections, and annual product reviewsDrive quality system improvements and track key quality metricsPartner with CMOs and suppliers on validation, tech transfer, and qualification activitiesMentor and develop junior QA staff
