Quality Control Manager, Animal Biologics

Job Description

Position Description:

Under the Site Quality Head's direction, the QC Lab Manager oversees guidance and supervision for QC Specialists and Technicians to fulfill testing and support activities.

The role encompasses responsibility for Animal biologics, including animal safety/potency testing and other logistics, bacteriology/sterility testing, team development for seasoned QC analysts, maintaining a comprehensive training program, and fostering a compliant and safe culture through policy implementation. This dynamic position operates within a fast-paced setting and involves managing 10-15 direct reports.

Additional Responsibilities:

• Oversee the QC team, providing management, coaching, and mentorship to cultivate technical expertise. Foster a diverse talent pool equipped for success and encourage collaboration, teamwork, and transparent communication.

• Conduct testing of final and bulk products, raw materials, and demonstrate proficiency in the analytical techniques relevant to the supported laboratories.

• Handle Animal biologics, encompassing potency, safety testing and animal care, as well as study director for IACUC, and other related projects.

• Author, review, revise, and approve SOPs, Quality Control Procedures, and other critical business documents.

• Supervise the QC training program to guarantee employee competency and qualification for their roles.

• Evaluate data critically for product release, advising on acceptance or rejection.

• Maintain records, devise improvement strategies, and manage tracking functions like corrective actions and special projects.

• Lead or assist in Investigations, Root Cause Analysis, CAPA implementation, and effectiveness assessments.

• Lead or aid in the effective Change Control of processes and documentation.

• Investigate safety and environmental incidents, modeling a safe and compliant culture in the laboratories.

• Support internal audits and regulatory lab inspections, acting as a subject matter expert.

• Serve as a resource and intermediary between technicians and support groups to ensure seamless operations.

Education Minimum Requirement:

• Bachelor’s degree in biology, Microbiology, Virology, Biochemistry, or related field

Required Experience and Skills

• Minimum five (5) years of laboratory, manufacturing, or quality experience in a cGMP environment.

• Working knowledge in the biotech industry with specific understanding of QC operations, regulatory agency engagement and ability to gain alignment on strategy.

• Demonstrated principled verbal and written communications.

• Servant Leadership Mindset

• Excellent interpersonal communication skills

• Demonstrated ability or aptitude for continuous learning and analytical problem solving with experience in root cause analysis and CAPA deployment.

• Animal care and biologics testing experience

Preferred Experience and Skills

• Experience developing and improving methods for biological and/or biochemical assays.

• Continuous Improvement and Lean methodology experience.

• Strong knowledge of USDA, GMP, regulation regarding vaccine manufacture

• Assay validation methods and report writing

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to