Job Description

Under general direction of the Executive Director, Wilson Quality Operations, the Director, Quality Control is responsible for administration of the Wilson Laboratory, including the North American Stability Unit (NASU-Wilson), as well as Release Laboratory activities which support the Wilson site and multiple other sites through the completion of raw material, microbiological and other testing (as required).

The incumbent will manage Wilson Laboratory activities to ensure compliance with all regulations, cGMPs, GLPs, et cetera, in support of domestic and international release/stability requirements. The Director will be responsible for leading a staff of 5-8 direct reports, which support a staff of approximately 65 employees. The Director is responsible for management of capital expenditure, profit planning and budget oversight. The incumbent is responsible for ensuring continuous improvement of laboratory operations and establishing and promoting a strong inclusive culture within the laboratory operation. Executes activities to meet or exceed customer expectations through a staff of professionals at the B.S., B.A., M.S., and Ph.D. levels.

• Manages a staff of 5-8 direct reports and oversees operation of the laboratory consisting of approximately 65 employees.
• Responsible for administrative and personnel actions such as hiring, transfers, training, salary, and appraisal administration.
• The incumbent is responsible for the management of necessary personnel, equipment, and resources to operate the following disciplines within the laboratory and ensure customer expectations are met or exceeded: technical support, training, stability and finished product release, active pharmaceutical ingredient analytical testing, finished product release and stability testing, raw material/component testing, microbiological testing and special testing upon request.
• Acts as a key regulatory compliance liaison to interface with regulatory agencies during audits of assigned areas.
• Performs duties and responsibilities of the Executive Director associated with the above in his/her absence.
• Reports to the Executive Director of Quality Operations for general advice and instruction, but normally handles routine matters independently, consulting the Executive Director on major problems only.
• Performs other duties as assigned.
• Assures that the Wilson laboratory maintains the necessary human and capital resources to meet present and future needs of operation and manages those resources to meet annual profit plan and budget requirements. Ensures the establishment of a robust talent management program within the laboratory and ensures supervisory staff develops the technical, business process and leadership skills of the laboratory staff. Establishes a strong inclusive culture within the laboratory through active demonstration of inclusive behaviors, and establishment of training and business processes which promote supervisory and employee engagement.
• Ensures that all policies (SOPs, QSs, SATs, Departmental Policies,) are maintained and adhered to within the laboratory. Participates in the generation and interpretation of divisional policies/guidelines. Actively participates in Plant/Quality committees and works with multi-functional/multi-site Quality team, Planning, Manufacturing, Packaging, Maintenance, and others as required to resolve tactical issues, and satisfy quality and production needs.
• Responsible for knowledge of cGMP's, cGLP's and laboratory safety, as well as the transfer of that knowledge to employees.
• Routinely makes decisions using cGMP's, cGLP's and safety knowledge as a guide. Edits, writes, and/or approves departmental SOP's.
• Manages Quality Assurance within the laboratory in accordance with company policy and applicable government regulations.
• Makes provisions to assure job responsibilities of the Quality Assurance area are conducted in a timely and reliable manner to meet production demands.
• Ensures all laboratory deviations are properly investigated and provides final approval for all investigations.
• Ensures a robust deviation management program is executed to ensure effective root cause analysis and corrective and preventative action identification/completion.
• Aligns resources with business unit needs to ensure on time execution and release of testing results (meeting customer and regulatory expectations).
• Manages activities to identify and correct problems, emphasizing prompt and definitive resolution to minimize adverse impact and reoccurrence.
• Ensures achievement of laboratory, Quality department and Wilson site objectives (e.g., compliance, inclusive culture, continuous improvement).
• Oversees laboratory computer and network support including security, maintenance, automation, validation, qualification, and system upgrade activities. Independently leads appropriate root cause analysis and corrective action identification for raw material, microbiological and vendor-related deviations/investigations.

• Bachelor's Degree in Chemistry, Pharmacy, Biology, Engineering, or a related science with nine (9) years of people management, regulatory compliance, resource management, and process improvement in relation to pharmaceutical industry.

• Minimum of four years of management experience required.
• Solid understanding of cGMPs, GLPs, and regulations required.
• Demonstrated leadership capabilities required.

• Experience in more than one functional area, including laboratory management.