Quality Systems Consultant – 21 CFR Part 11 Compliance

Responsibilities

• Lead and support assessments of laboratory environments, operational processes, and electronic systems for compliance with 21 CFR Part 11.
• Evaluate computerized systems and electronic records/signature controls to identify compliance gaps and recommend remediation strategies.
• Perform and facilitate quality and compliance risk assessments.
• Support laboratory equipment compliance initiatives, including computerized laboratory instrumentation.
• Develop, review, and improve quality system documentation, procedures, protocols, and compliance records.
• Partner with cross-functional Quality, Manufacturing, Laboratory, Validation, and IT teams to implement compliant solutions.
• Provide technical recommendations and compliance guidance while collaborating with internal quality leadership responsible for final approvals.
• Contribute to long-term quality system improvement initiatives and regulatory inspection readiness.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Quality, or a related technical discipline.
• 10+ years of experience within FDA-regulated pharmaceutical, biotechnology, or medical device environments.
• Demonstrated expertise in 21 CFR Part 11 compliance, including electronic records, electronic signatures, and computerized systems.
• Strong background conducting compliance and quality risk assessments.
• Experience supporting laboratory systems, manufacturing systems, or GxP computerized systems.
• Working knowledge of FDA Quality System expectations, GxP regulations, data integrity principles, and computerized system compliance.
• Excellent technical writing and documentation review skills.
• Proven ability to work independently, prioritize complex initiatives, and provide practical compliance recommendations with minimal supervision.

Preferred Experience

• Computerized System Validation (CSV) experience.
• Experience supporting enterprise quality system remediation or compliance transformation initiatives.
• Familiarity with laboratory instrumentation, LIMS, MES, ERP, or other GxP computerized systems.
• Experience preparing organizations for FDA or international regulatory inspections.

Pay

Competitive compensation commensurate with experience.

Schedule

Long-term consulting engagement with an anticipated duration of 18–24 months, with a strong likelihood of extension.

Engagement Details

Opportunity to support a highly visible, enterprise-wide compliance initiative.