Lead the efforts of QA personnel responsible for the testing, investigations, and method transfer activities to ensure compliance with all regulatory requirements, company policies, values, and goals
Responsible for setting strategy direction for the Quality Assurance Dept. and team
Provide leadership for lot release, incoming quality, manufacturing, and labs investigations, change control and corrective and preventative action review/approval, manufacturing support, record review/approval, and ongoing projects support (if any)
Support team by guidance and coaching and provide direction/approval of activities and decisions
Cultivate and reinforce appropriate group values, ethics, norms, and behaviors
Share oversight to individuals and team on personal development, performance, and quality related issues. Write and deliver performance reviews
Responsible for supporting all planned and unplanned manufacturing and labs deviations, review and approval of product and equipment change controls (including SOPs and master batch records)
Conduct impact assess to design changes and participate/coordinate CAPA Review Board
Maintain the structure to ensure that all quality commitments and timelines are tracked and met.
Work directly with internal and external customers to assure Best-in-Class expectations for quality are met if not exceeded
Analyze trends, quality metrics and other data to identify quality and compliance gaps
Participates in the recruitment, selection, promotion, and performance management of QA employees.
Requirements
Candidates should possess B.Sc Degrees with 2+ years relevant work experience.