Sr. Manager Quality Assurance
Core
Administers Laboratory Quality Assurance, Compliance, and QA Document Control to assure timely delivery of Biosimilar Drug Products and manage quality systems for the Wilson facility.
Role type
Senior Manager, Quality Assurance (Biosimilars)
Builds
Biosimilar drug products
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
cGMP compliance, regulatory inspection management, quality system administration, discrepancy investigation, budget management, team leadership, change control, validation documentation, annual product review coordination
Preferred skills
ISO 14001, ISO 50001, ISO 45001 knowledge
Technologies
None stated
Responsibilities
Establish and administer Quality Assurance processes for the Wilson facility; review and approve SOPs, validation docs, and discrepancy reports; direct product complaint investigations; coordinate Annual Product Quality Reports; participate in FDA/Regulatory inspections; develop HR and manage budget for QA functions.
Seniority
Senior, Management
