Job Description

• 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.