Job Description

Position Responsibilities & Deliverables . Maintain a contemporary knowledge of processes and procedures, including the principles and practices of good data management (ALCOA); guide and advise site colleagues in the same. . Communicate with site management regarding project milestones and status in alignment with their role and goals. . Promote a culture of lean operations by reviewing existing work practices and reducing non-value-added activities, continuously improve quality systems and practices on site with respect to achieving compliance, reducing waste, and improving efficiencies . Develop meaningful quality KPI's with the QAQC teams, present trend reports for Quality Management Reviews and coordinate, develop and track QC Operations metrics. . Build connections for Tuas QA colleagues to the broader PGS network SMEs and Communities of Practices to facilitate sharing of best practices, issue resolution and the exchange of knowledge. . Mentor the current incumbent Sr. QA Manager, build QA team competency and decision-making capabilities, and establish strategies to foster Operations and QA collaboration.Education and Experience . Degree in Science / Engineering or a related discipline. . Minimum 10 years working in pharmaceutical manufacturing and quality operations, or an equivalent combination of work experience and education. . Minimum 5 years leading a Quality Assurance team in a multi-product, GMP, FDA regulated site directly supporting manufacturing operations and investigations. . Demonstrated capability and experience in process simplification, critical thinking, project management, compliance improvement initiatives, complex manufacturing investigations, and mentoring others. . Familiar with process-centric team concepts and process improvement tools. . Experience in API manufacturing, and computerized manufacturing systems is preferred but not essential.
Not Specified