The Site Quality Control Labs Leader role is accountable for product quality control testing in a strict GMP compliance environment. The Role ensures the QC function meets all regulatory compliance requirements and GMPs.
The Site Quality Control Leader is a key stakeholder in fostering the Quality Culture and takes proactive steps to prevent any decay in the state of quality and compliance at the site.
The position reports to the Site Quality Leader.
The Site Quality Control Leader is a member of the Quality Operations Leadership team and participates in setting the strategic direction of the quality unit as well as managing day-to-day quality control operations. The position also is expected drive a culture of worker safety and continuous improvement.
The Quality Control Leader uses data and metrics to meet product supply imperatives and drive continuous improvement in site quality systems as well as Product Quality.
- Direct and oversee the Quality Control Laboratory team leaders. Plan, initiate and manage the policies, processes and procedures for the Quality Control Laboratories to monitor the quality of biological and pharmaceutical products manufactured, managed and/or tested by Lincoln Operations (including White Hall, and Charles City) ensuring that global compliance, Zoetis quality standards and customer expectations are met.
- Participate and lead in yearly and long-range budget planning of personnel, capital equipment, and operating expenses.
- Develop and maintain both performance and predictive metrics to guide laboratory operations and identify capacity restraints and issues.
- Ensure effective training programs are in place to train and monitor the performance of QC personnel to ensure continuity of section operations.
- Manage the control laboratory leaders of highly trained scientific personnel in traditional and contemporary chemical, immunological, In-Vivo, microbiological and virology testing of biological/vaccine products, including extraneous agent, raw material testing, and environmental monitoring.
- Represent Quality Operations by actively participating with technical groups within GMS and VMRD to transfer and launch new products, drive CIPs, and investigate any product or testing issues.
- Direct successful assay development programs within Quality Operations to maintain testing procedures at the highest levels
- Direct and ensure a dynamic system of standard operating procedures and assure compliance is maintained within the Quality Control Laboratories.
Staff and Leadership Responsibilities
- Leadership Development / Coaching of Staff; Creation of Learning Organization for the QC Laboratories
- Participate in the Quality Culture across the Site.
- Ensure Training and Development plans are in place for all QC associates.
- Development of Site QC operations budget and resource planning for roll up to the Site Quality Budget.
- Support the development of Quality Operations goals and targets as part of the organization’s strategic plan.
Education and Experience
- B.S. with 14 years, M.S. with 12 years, or Ph.D. with 9 years, experience in biological or pharmaceutical sciences, testing, and/or related discipline.
- A minimum of five years QC management experience including budget and supervisory responsibilities.
- A minimum of five years progressive experience in the quality assurance, manufacturing, quality control, or regulatory affairs function of veterinary or human pharmaceuticals or biological.
- A thorough familiarity with testing requirements of USP, EP and 9 CFR for biological and pharmaceutical products, including the Regulations (FDA, USDA & VMD) for biological and pharmaceutical products and their application to Quality Control Laboratories.
Technical Skills and Competencies
- Does well in a Change Management environment, Acts as a Change Agent
- Problem solver, root cause analysis methodology
- Process oriented mindset; data and continuous improvement orientation
- Able to work well in complex environment
Physical Position Requirements
- Position located in Lincoln, NE
- Minimal off-site travel
- This position requires sitting, standing, and walking with occasional overtime/weekend work.
- Must wear appropriate gowning and PPE (Personal Protective Equipment) in laboratories.