Provides leadership and supervise a team of data reviewers through daily contact and maintenance of Visual Control Tools. This person will participate in the daily departmental huddles to ensure that project and customer timelines are met. The Team Leader is responsible for the performance of the team members including Right First Time execution and On Time Delivery of the work. This is accomplished through coaching, ensuring that the reviewers work schedules are level loaded, and identifying, tracking and removing barriers to execution of the work. The Team Leader is also responsible for training their team members in the use of standard work, evaluating the integrity of data and assisting in OOS/UR investigations constantly ensuring compliance with cGMP and SOPs. Their team ensures conformance and adherence of data and documentation to test methods, protocols and specifications. Through monitoring the execution of the work and the department and team’s KPIs, the Team Leader also determines opportunities to increase quality or efficiency of lab processes. The Team Leader is responsible for providing input on the individual performance of team members, including completion of weekly 1:1’s and the bi-annual performance reviews.
Provides leadership to assigned staff by performing the following: leading organziational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed; meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best. Coordinates data review across the one site laboratory organisation. HPLC, UPLC, Dissolution and EMPOWER CDS(or other similar CDS) experience essential. Designs, develops and periodically review/update SOPs related to data review. Ensure strict confomrance to the principles of ALCOA. Keeps up to date with advances in analytical, pharmaceutical and regulatory developments, in particular those related to data review. Performs other duties as assigned.
Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
Manages the coordination of the activities of a section or department with responsibility for results.
Bachelor’s degree in Science, Pharmaceutical Analysis, Analytical Instrumentation or related field.
Minimum of 5 years experience in pharmaceutical analysis. Previous supervisory and training experience preferred.