Corporate Director of Quality – Life Sciences

🔥 0 minutes ago

🌲 North Carolina, Virginia – Remote

🌲 North Carolina – Remote ⚔️ Virginia – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 10%

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Microbac Laboratories, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1969

🍽️ Food & Beverage

🏥 Healthcare

📦 Logistics

Food & Beverage • Healthcare • Logistics

Microbac Laboratories, Inc. is a family-owned, third-party analytical testing laboratory with over 50 years of experience delivering accredited testing services across environmental, food, life sciences, and specialty testing. Operating a nationwide network of 30+ laboratories, Microbac provides accurate, compliance-focused results and consulting to support regulatory requirements, quality assurance, and public health. The company emphasizes reliability, scientific rigor, and customizable one-stop testing solutions for businesses and institutions.

📋 Description

• Provide strategic and operational leadership for Quality Systems across Microbac's Life Sciences line of business • Lead, develop, and mentor Quality Managers and quality personnel supporting laboratories in Sterling, Virginia and Wilson, North Carolina • Ensure consistent implementation, maintenance, standardization, and continuous improvement of laboratory Quality Systems • Provide independent Quality oversight and final quality authority for laboratory operations, including authority to stop testing or data release when quality or data integrity concerns exist • Oversee internal, client, regulatory, and accreditation audits and inspections, including inspection readiness, audit responses, corrective action commitments, and resolution of findings • Monitor quality performance, quality events, deviations, CAPAs, complaints, audit findings, data integrity concerns, and other quality metrics • Partner with Operations, Technical Services, Business Development, Corporate Quality & Safety, laboratory leadership, and other functions • Ensure GMP-, GLP-, and GCP-regulated activities comply with regulations, guidance, protocols, quality agreements, client requirements, approved procedures, and data integrity practices • Monitor FDA and other regulatory requirements, industry guidance, accreditation requirements, and client expectations; lead required Quality System changes • Serve as senior Life Sciences Quality representative in client meetings, regulatory interactions, inspections, quality agreement discussions, and escalated quality matters • Partner in Management Review and formal Quality System evaluations • Drive standardized and scalable quality practices between the Sterling and Wilson laboratories while maintaining site-specific requirements • Split time between office and laboratory environments and travel 50%–75%

🎯 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 • Ability to meet physical requirements, including occasionally exerting up to 50 pounds of force • Must pass a drug test before beginning work; refusal results in disqualification

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Life insurance • Disability insurance • Generous paid time off, including vacation, holidays, and flextime • Wellness program • Referral bonus • Tuition reimbursement • Competitive pay and benefits