Corporate Director of Quality - Life Sciences

About Microbac

Microbac Laboratories, Inc. is a premier commercial laboratory testing firm that partners with clients nationwide, offering laboratory solutions to life science, food and nutrition, and environmental industries. We serve our clients with the utmost expertise and respect for their market requirements, constraints, and challenges. We embody a company-wide commitment to exceptional customer experience, refined by over 50 years of trusted, analytical, and measurement experience.

Job Summary

The Corporate Director of Quality - Life Sciences reports to the Chief Quality, Safety & Risk Officer and provides strategic and operational leadership for Quality Systems across the Life Sciences line of business. This role is responsible for the development, implementation, maintenance, standardization, and continuous improvement of Quality Systems supporting laboratory operations conducted under Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), applicable regulatory requirements, accreditation standards, client quality agreements, and company requirements.

Essential Functions

• Provide strategic leadership and oversight of the Quality Management Systems for the Life Sciences laboratories in Sterling, VA and Wilson, NC, ensuring consistent application of corporate quality requirements and compliance with applicable GMP, GLP, GCP, regulatory, accreditation, and client-specific requirements.
• Lead, develop, and mentor the laboratory Quality Managers and associated quality personnel, establishing clear expectations, accountability, standardized practices, and effective execution of quality responsibilities across both locations.
• Ensure effective implementation, maintenance, and continuous improvement of laboratory quality systems, including controlled documents, training and competency, data integrity, change control, deviations/nonconformances, investigations, CAPA, risk management, equipment and computerized system quality requirements, and record retention.
• Provide independent Quality oversight and final quality authority for laboratory operations, including assessment of data acceptability, investigation adequacy, regulatory compliance, and the authority to stop testing or data release when quality or data integrity concerns exist.
• Oversee internal, client, regulatory, and accreditation audits and inspections, including laboratory inspection readiness, audit response development, corrective action commitments, and verification of timely and effective resolution of findings.
• Monitor laboratory quality performance and identify systemic or recurring risks through review of quality events, deviations, CAPAs, complaints, revised reports, audit findings, data integrity concerns, and other quality metrics; communicate significant trends, risks, and improvement opportunities to laboratory and executive leadership.
• Partner with laboratory Operations, Technical leadership, and other corporate functions to ensure quality requirements are appropriately incorporated into laboratory processes, new services, method implementation and validation, equipment and system changes, facility changes, client commitments, and other business initiatives.
• Ensure laboratory activities supporting GMP, GLP, and GCP-regulated work are performed in accordance with applicable regulations, guidance, protocols, quality agreements, client requirements, approved procedures, and good documentation and data integrity practices.
• Monitor new and changing FDA and other applicable regulatory requirements, industry guidance, accreditation requirements, and client expectations; assess organizational impact and lead implementation of necessary quality system changes across the Life Sciences laboratories.
• Serve as the senior Life Sciences Quality representative in client meetings, regulatory interactions, inspections, quality agreement discussions, escalated quality matters, and other forums requiring senior-level quality expertise and decision-making.
• Partner with laboratory leadership in Management Review and other formal quality system evaluations to assess overall QMS effectiveness, resource needs, significant risks, compliance status, and opportunities for continuous improvement.
• Drive standardization and scalable quality practices between the Sterling and Wilson laboratories while ensuring site-specific regulatory, technical, client, and operational requirements are appropriately maintained.

Minimum Requirements

• Bachelor's degree in Biology, Chemistry, Microbiology, Biochemistry, Pharmaceutical Sciences, Life Sciences, or another related scientific discipline from an accredited four-year college or university.
• Minimum of 10 years of progressively responsible experience in regulated laboratory, pharmaceutical, biotechnology, contract research organizations (CROs), or similar environments.
• Experience in GMP, GLP, GCP, and other relevant regulatory frameworks.
• Proven ability to manage and mentor quality personnel.
• Strong understanding of data integrity principles and practices.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively with cross-functional teams.