Corporate Director of Quality - Life Sciences

Microbac•Remote, US,

1d•Remote

About The Position

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. As a privately held third-party testing company, Microbac operates with a commitment to our workforce, safety, quality, and compliance. 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. This position provides direct leadership and oversight of the Quality Managers supporting the Life Sciences laboratories located in Sterling, Virginia and Wilson, North Carolina. The Corporate Director is responsible for ensuring consistent application of quality requirements between the laboratories while maintaining appropriate systems and controls based upon the regulatory framework and services performed at each location. The Corporate Director serves as the senior Quality leader for Life Sciences and partners closely with laboratory leadership, Operations, Technical Services, Business Development, and Corporate Quality & Safety to ensure laboratory activities are performed in a state of compliance and that generated data is accurate, attributable, complete, consistent, enduring, available, and scientifically defensible. This position is responsible for ensuring effective laboratory Quality Systems governing areas including document and records control, training and personnel qualification, equipment and computerized systems, data integrity, deviations and nonconformances, investigations, corrective and preventive actions, change control, method qualification/validation/verification, vendor and supplier qualification, internal and external audits, client complaints, Quality Agreements, and regulatory inspection readiness. The Corporate Director is expected to interact with clients, regulatory agencies, auditors, and other external stakeholders on complex Quality and compliance matters and serve as a senior authority on Quality Systems, regulatory compliance, and data integrity within the Life Sciences business.

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, contract testing, medical device, or related Life Sciences environments, including significant Quality and leadership experience.
Minimum of 5 years of Quality management or Quality Unit leadership experience within a GMP-, GLP-, GCP-, or similarly regulated laboratory environment preferred.
Demonstrated experience providing Quality oversight for laboratory operations subject to GMP and/or GLP regulatory requirements; experience supporting GCP-regulated activities strongly preferred.
Strong working knowledge of FDA-regulated Quality Systems and laboratory compliance expectations, including applicable requirements of 21 CFR Parts 11, 58, 210, and 211.
Demonstrated experience with regulatory inspections and/or significant client Quality audits within a regulated Life Sciences environment.
Experience managing and evaluating deviations, OOS/OOT investigations, CAPAs, change controls, internal audits, data integrity events, and other regulated Quality System processes.
Strong understanding of laboratory data integrity principles, including ALCOA/ALCOA+ expectations and controls applicable to electronic and paper laboratory records.
Experience with computerized system validation, electronic laboratory systems, audit trails, electronic records, and applicable 21 CFR Part 11 expectations preferred.
Experience with laboratory method validation, verification, qualification, or transfer processes and associated Quality oversight.
Experience reviewing or administering client Quality Agreements and regulated contractual Quality requirements preferred.
Demonstrated ability to lead, develop, mentor, and hold Quality professionals accountable across multiple laboratory locations.
Strong knowledge of Quality risk management, root cause analysis, investigation practices, CAPA effectiveness, and continuous improvement principles.
Ability to interpret complex regulatory requirements and translate those requirements into practical, scalable laboratory Quality Systems.
Strong written and verbal communication skills with demonstrated ability to communicate effectively with laboratory personnel, senior executives, clients, auditors, and regulatory authorities.
Ability to exercise independent judgment and make difficult Quality and compliance decisions when necessary to protect data integrity, regulatory compliance, clients, and the company.
Collaborative work approach aligned with Microbac’s corporate values.
Proficiency with electronic Quality Management Systems, laboratory information systems, document management systems, and Microsoft Office Suite.

Nice To Haves

Minimum of 5 years of Quality management or Quality Unit leadership experience within a GMP-, GLP-, GCP-, or similarly regulated laboratory environment
Experience supporting GCP-regulated activities
Experience with computerized system validation, electronic laboratory systems, audit trails, electronic records, and applicable 21 CFR Part 11 expectations
Experience reviewing or administering client Quality Agreements and regulated contractual Quality requirements

Responsibilities

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.