Manager, QC Compendial Testing

The Manager, Compendial Testing is accountable for cGMP compliant laboratory operations according to GMP guidelines. This role manages and supervises the QC Compendial Testing team performing testing according to USP/EP/JP guidelines to support drug substance and drug product manufacturing processes. The Manager, Compendial Testing provides managerial support for troubleshooting of complex investigations and optimizing laboratory systems and ensures the laboratory is maintained in a state of cGMP compliance. This role is the technical subject matter expert (SME) and participates in assessing the testing of compendial methods and represents the QC team during regulatory and customer audits. In addition, the Manager, Compendial testing implements higher level strategy for raw materials testing, and develops analytical and materials disposition processes with global stakeholders.

What You’ll Do

• Ensures GMP compliant laboratory operations according to guidelines.
• Manages daily activities of the QC Compendial testing team and assures dedicated focus on testing, release, change management and Tech Transfer activities in support of new and existing customer programs.
• Ensures overall performance of QC Compendial testing according to key performance indicators (KPIs).
• Oversees and manages laboratory exceptions and investigations and assures timely closure of cGMP KPI deliverables within the group.
• Motivates team to perform as efficiently as possible to reduce turn-around-times for testing; approves and ensures manufacturing is running and tech transfer activities timelines are met.
• Collaborates with cross-department management on overall compendial testing strategy to support site operations.
• Authors procedures, documents and reports, as needed, to support compendial testing and test directives.
• Prioritizes and focuses on optimized laboratory systems, including the use of IT systems (e.g. Labware), identifies and implements needed procedural and/or policy changes in areas where needed.
• Enforces established policies, processes and procedures and identifies areas where enhancements will improve daily work.
• Leads cross-functional collaboration with QC Analytical Development, QC Microbiology, QC Program Management, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Biotechnologies objectives.
• Authors, reviews, and approves data reports, out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, Corrective and Preventative Actions (CAPAs), and Change Controls, as needed.
• Ensures team and laboratory maintains inspection readiness for customer visits, audits and regulatory inspections following cGMP guidelines and FUJIFILM Biotechnologies processes.
• Ensures the timely delivery of results within deadlines by effectively managing the performance.
• Represents QC in relevant internal and external cross-functional meetings and projects to ensure delivery of objectives.
• Executes managerial tasks per the FUJIFILM Biotechnologies policies including coaching, guidance, and development of team members.
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees.
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.).
• Coaches and guides direct reports to foster professional development.
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed.
• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution.
• Performs other duties, as assigned.

Knowledge, Kills, or Abilities

• Displays and advanced knowledge of regulatory requirements for compendial testing (e.g., cGMPs, USP, EP, JP, and ICH).
• Possesses a broad knowledge of quality control operations, systems, and directives.
• Demonstrates excellent leadership and people management skills.
• Demonstrates excellent technical writing skills, and clear oral and written presentation abilities.
• Ability to make clear and informed decisions with limited information based on previous experience with QC testing.
• Able to effectively communicate with management, peers, and subordinates.
• Displays strong organizational skills with an ability to multi-task and coordinate multiple activities in parallel.
• Demonstrates problem solving skills and instrument/method troubleshooting skills.
• Able to work effectively, independently and within a team framework, across all business areas and levels of the organization.
• Ability to coach, lead, and develop individual contributors.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• Bachelor’s degree in chemistry, Microbiology, Biological Sciences, Engineering or related science with 4\+ years of related experience; OR,
• Master’s degree in chemistry, Microbiology, Biological Sciences, Engineering or related science with 2\+ years of related experience.
• 4\+ years’ experience managing people.
• Experience working in a changing, project driven organization.
• Previous experience directly supporting function.
• Experience with regulatory inspections, investigations and change management.
• Experience in pharmaceutical / biological manufacturing operations preferred.
• Experience leading others in a pharmaceutical/biological manufacturing facility.

Preferred Qualifications

• 5\+ years of experience in a GMP environment.
• 4\+ years of experience managing a raw materials laboratory to support GMP production.
• Experience with Microsoft Office, Smartsheet and laboratory LIMS and ERP systems (e.g., SAP).