Corporate Director of Quality – Life Sciences

This is a fully remote position, open to applicants in North Carolina, +1 more state.

📋 Description

• Provide strategic and operational guidance for Quality Systems within Microbac's Life Sciences division.

• Lead, mentor, and develop Quality Managers and quality personnel supporting laboratories located in Sterling, Virginia, and Wilson, North Carolina.

• Ensure the consistent implementation, maintenance, standardization, and continuous enhancement of laboratory Quality Systems.

• Offer independent Quality oversight and serve as the final quality authority for laboratory operations, including the authority to halt testing or data release in the event of quality or data integrity issues.

• Supervise internal, client, regulatory, and accreditation audits and inspections, including preparation for inspections, audit responses, commitments to corrective actions, and resolution of findings.

• Monitor quality performance, quality events, deviations, CAPAs, complaints, audit findings, data integrity issues, and other quality metrics.

• Collaborate with Operations, Technical Services, Business Development, Corporate Quality & Safety, laboratory leadership, and other departments.

• Ensure compliance with GMP, GLP, and GCP regulations as well as guidance, protocols, quality agreements, client requirements, approved procedures, and data integrity practices.

• Keep abreast of FDA and other regulatory requirements, industry guidelines, accreditation standards, and client expectations; lead necessary changes to Quality Systems.

• Act as the senior Life Sciences Quality representative in client meetings, regulatory discussions, inspections, quality agreement negotiations, and escalated quality issues.

• Participate in Management Review and formal evaluations of the Quality System.

• Promote standardized and scalable quality practices between the Sterling and Wilson laboratories while accommodating site-specific needs.

• Divide time between office and laboratory settings and travel 50%–75%.

⛳️ Requirements

• A Bachelor's degree in Biology, Chemistry, Microbiology, Biochemistry, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline from an accredited four-year institution.

• At least 10 years of progressively responsible experience in regulated laboratory settings, pharmaceutical, biotechnology, contract research, contract testing, medical device, or related Life Sciences environments, including substantial Quality and leadership experience.

• A minimum of 5 years of experience in Quality management or Quality Unit leadership within a GMP, GLP, GCP, or similarly regulated laboratory environment is preferred.

• Proven experience in providing Quality oversight for laboratory operations that are subject to GMP and/or GLP regulatory requirements; experience in supporting GCP-regulated activities is strongly preferred.

• Comprehensive working knowledge of FDA-regulated Quality Systems and laboratory compliance expectations, including relevant 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 context.

• Experience in managing and evaluating deviations, out-of-specification/out-of-trend 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 both electronic and paper laboratory records.

• Experience with computerized system validation, electronic laboratory systems, audit trails, electronic records, and relevant 21 CFR Part 11 expectations is preferred.

• Familiarity with laboratory method validation, verification, qualification, or transfer processes, along with the associated Quality oversight.

• Experience in reviewing or managing client Quality Agreements and regulated contractual Quality requirements is preferred.

• Proven ability to lead, develop, mentor, and hold Quality professionals accountable across multiple laboratory sites.

• 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 them into practical, scalable laboratory Quality Systems.

• Excellent written and verbal communication skills, with a demonstrated ability to communicate effectively with laboratory personnel, senior executives, clients, auditors, and regulatory authorities.

• Capability to exercise independent judgment and make challenging Quality and compliance decisions when necessary to safeguard data integrity, regulatory compliance, clients, and the company.

• A collaborative work approach that aligns with Microbac's corporate values.

• Proficiency with electronic Quality Management Systems, laboratory information systems, document management systems, and the Microsoft Office Suite.

• Ability to meet physical requirements, including occasionally exerting up to 50 pounds of force.

• Must pass a drug test prior to commencing work; refusal will result in disqualification.

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• Life insurance

• Disability insurance

• Generous paid time off, including vacation, holidays, and flexible time

• Wellness program

• Referral bonus

• Tuition reimbursement

• Competitive pay and benefits