About This Role
This role involves establishing the Quality structure and ensuring processes conform to company policies and comply with cGMPs, Health Agency regulations, and other applicable governing regulations. The successful candidate will lead the sterile Drug Product Quality Assurance team, collaborating with global teams and the biotechnology industry to develop and execute multiple Quality Assurance systems and processes.
Responsibilities
- Act as the leader of the sterile Drug Product (DP) Quality Assurance team
- Ensure that processes for the manufacture of biologics DP have been conducted in compliance with GMP, registered marketing authorisation, and associated regulatory requirements
- Drive compliance direction for the site by ensuring adherence to divisional policies, guidelines, and regulatory requirements
- Review and approve GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations
- Assist in and facilitate investigations, ensuring effective Root Cause Analysis and CAPAs
- Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site
- Advocate for continuous improvement in the Quality Management Systems
- Provide Quality oversight to the qualification/validation, technical transfers, regulatory approvals, and commercial operations for sterile DP at the facility
- Manage batch record review, discrepancy reporting, investigations, and CAPAs associated with Drug Product Release
- Drive opportunities for continuous improvement
- Provide audit support and participate in response team for audits and inspections by Health Authorities
- Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions
- Manage team of shift specialists within the Drug Product QA Operations organization
Requirements
- Minimum of 10 years’ experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations
- Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends
- At least 5 years of operational experience in a regulated environment
- Experience in supporting tech transfer or process validation either internally or externally
- Experience in drug product quality operations and batch record review
- Demonstrated knowledge of Cleaning in Place, Cleaning out of Place, Sanitize in Place
- Demonstrated understanding of continuous quality / process improvement tools (e.g. DMAIC, Lean QA, 5S etc)
