Our client is looking for an innovative, customer-focused and results driven individual to join their Site Quality Operations team.  The individual appointed to this position will report to the Director of Quality Control, and will be responsible for providing leadership and guidance within the Quality Control Chemistry Department.  The role is accountable for all aspects of in-process and final product release testing, ensuring that testing process and procedures are compliant with local and global health, safety and regulatory standards. The incumbent will manage the day-to-day operations of their area including personnel activities, technical oversight, testing workflow and capacity management and budget control. In addition, the individual will provide assistance to Industrial Operations and Research and Development groups for investigations, trouble-shooting or risk assessments relevant to vaccine products, tests or testing equipment.  As a member of the QC Management Team, provide leadership for change initiatives and help identify and implement continuous improvement opportunities.

Responsibilities include:

1. Manage the organization, planning and day-to-day activities of QC Chemistry, ensuring efficient and effective support for both in-process and finished product testing. Ensure department can deliver high quality testing services in a safe and compliant work environment. Support the preparation of annual budgets, monitor spending and control costs by effective utilization of personnel and materials. Develop and implement plans for external testing or services as needed to achieve departmental deliverables.

2. Ensure the accuracy and compliance of departmental test conduct, test results, and documentation practices. Provide analytical methods that are appropriate, and ensure that equipment used in the testing are properly calibrated and maintained, with accompanying documentation. Conduct scientifically sound investigations into atypical or out-of-specification laboratory data with an emphasis on finding and addressing root causes. Trend departmental data and provide input to Annual Product Review (APR) as requested.

3. Compile, analyze and correlate technical data and write laboratory reports or protocols in support of continuous improvement projects, test transfers, investigations, and regulatory agency updates or submissions. Interact with colleagues in local and global Industrial Operations, Research and Development and Regulatory Affairs as SME to communicate technical information in a professional and timely manner. Establish and assess quality performance metrics for the laboratory and identify opportunities for improvements in quality, service, control and costs.

4. Ensure all chemistry procedures and processes comply with organizational policies, and regulatory requirements. Participate in regulatory inspections and ensure responses and CAPA actions are completed by designated target date. Maintain working knowledge of regulatory requirements applicable to the industry. Perform review and approval of Standard Operating Procedures, Standard Work Instruction that detail the testing and maintenance of laboratory equipment and systems for technical content, and compliance with the pharmacopeia and cGMPs. Ensure test changes are fully assessed according to site Change Control and act as sponsor to approve Chemistry Change Control Requests (CCR’s).

5. Lead a team of 15-20 staff and ensure that professional development and training are aligned with current and future needs. Ensure compliance of direct reports with GxP and other quality and documentation requirements, and ensure department training is up to date to perform the designated cGMP activities and requirements for Health and Safety. Coach and motivate staff to perform efficiently and achieve objectives on time, on budget. Oversee the recruitment, hiring and training of new staff to ensure the competency of QC Chemistry remains aligned to business needs.

Qualifications Required:

• Minimum PhD in Chemistry or related discipline plus a minimum of five (5) years of previous relevant experience in a high volume laboratory setting, preferably a quality setting in a manufacturing environment. Candidates with a Master of Science degree and eight (8) or more years of previous relevant experience will be considered.
• Previous experience in pharmaceutical or biological Quality Control operations including industrial experience with Chemistry testing and regulatory compliance is essential.
• A demonstrated ability of working with severe time constraints is essential, as are strong interpersonal and communication skills within and beyond the QC Department.
• Excellent organizational skills and proficiency in the technical issues/practices within an analytical QC laboratory in support of a manufacturing environment are required. Knowledge of analytical testing methods, for example, HPLC, GC, FTIR, Spectrophotometry, Karl Fisher, vicometry, conductivity and wet analytical methods is also needed.
• Sound knowledge of cGMPs and pharmacopendial testing for US, Canada, Europe and Japan.
• Demonstrated leadership and supervisory abilities.