WH073 QA Head

Duties and Responsibilities:

• 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
• Ensure proper use of assets, budget, and personnel and  communicate effectively with key customers and partners, both within the site and outside as appropriate
• 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.  In addition, assist the senior leaders at the site in resource and budget preparations
• Responsible for driving process improvements within Drug Substance, Drug Product, Site support systems
• Actively  with urgency when necessary to resolve issues related to production or supply as it relates to investigations or other issues
• Coordinate planned and/or ad-hoc external audits and drive Internal Audit plan and share reports and outcome to the Site Management Team proposing continuous improvement action plan
• Responsible for driving cross-training across Drug Substance, Drug Product, Site staff resources (as well as potentially other areas of QA)
• 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

Competencies and Behaviors:

• Previous experience mentoring and coaching experienced Quality professionals
• Proven results using quality improvement tools and techniques  to drive improvements across different functions at Multicare’s Site
• Leading by example to be role model for others
• Collaborative approach and ability to build strong partnerships with cross-functional teams to drive results
• Demonstrate excellent communication, facilitation, and conflict resolution skills
• The drive for self-development, the ability to collaborate, and an action-oriented work ethic
• Excellent written and verbal skills in English
• Project Management experience and/or certification is a definite plus