Associate Director, QA Operations, Drug Substance

Position Responsibilities

• Acting in the role of leading the Drug Substance (DS) Quality Assurance team.
• Ensuring that the processes for the manufacture of biologics DS have been conducted in compliance with GMP, the registered marketing authorisation and the associated regulatory requirements.
• Driving compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.
• Reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations.
• Assisting in, and facilitating investigations, ensuring effective Root Cause Analysis and CAPAs.
• Identifying and facilitating major compliance initiatives to improve compliance status and overall operational efficiency of the site.
• Being an advocate of continuous improvement in the Quality Management Systems.
• Providing Quality oversight to the qualification/validation, technical transfers, regulatory approvals and commercial operations for DS at the facility.
• Responsible for the management of batch record review, discrepancy reporting, investigations and CAPAs associated with Drug Substance Release.
• Drives opportunities for continuous improvement.
• Providing audit support and participating in response team for audits and inspections by Health Authorities.
• Providing 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.
• Managing team of shift specialists within the Drug Substance QA Operations organization.

Qualifications & Experience

• Knowledge and Skills Requirements:
  • General: Seasoned Associate Director with a 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. Proven track record in delivering excellence.
  • Direct Experience: In Manufacture Of Antibody Drug Conjugates Preferred.
  • Technical: Must have 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 substance 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 (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).
  • People: Great communicator with proven ability to deliver excellence. Knowledge of relevant cGMPs, regulations and current industry trends related to Antibody Drug Conjugate drug substance Manufacturing. Experience with new product introductions and/or process qualification/technology transfer. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc. Excellent communication skills (written and oral).
• Education: Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or in a relevant discipline.