A. Essential 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 personneland 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
Job Requirements
B. Qualification/Knowledge/Experience:
Level of Education:
- Pharmacygraduate preferably with related post-graduate QMS degree or
Experience :
- Track record of leading the QA function at sound pharmaceutical organizations
Language:
- Excellent verbal, written and interpersonal communication skills. English fluency essential
IT Literacy :
C. 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