Responsibilities:

• Manage Quality Assurance team and activities related to the department
• Release of products manufactured on-site and at the CMO’s at all phases of their process
• Manage the site documentation center
• Develops and implements quality assurance procedures, systems and programs applicable to meet Corporate and regulatory compliance requirements.  Review and approve documents related to operations
• Maintain and work pro-actively to improve systems by assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility
• Support the preparation and management of regulatory inspections and third party audits, coordinate and ensure follow-up of audit responses and corrective actions
• Exercise oversight, by conducting periodic audits and identifying and tracking key performance indicator of the quality systems
• Work cross-functionally with Operations, Quality Control, Facilities/Engineering, Corporate Quality, and others departments across the organization
• Develops and implements strategies for timely compliant QA approval of clinical and commercial material (lots) to multiple jurisdictions
• Represent the Quality Assurance department on assigned project teams and internal meetings
• Ensure implementation and use of health and safety rules
• Lead Quality related meeting such as site Quality Council

Requirements:

• Requires as a minimum, Bachelors in science or engineering and 10 or more years of quality assurance experience in the biotechnology or pharmaceutical industry in a commercial environment
• Requires as a minimum, 5 years in personnel management in a quality assurance role