Quality Systems Consultant - 21 CFR Part 11 Compliance

Quality Systems Consultant - 21 CFR Part 11 Compliance

Contract | Long-Term Engagement (18-24+ Months)

Piper Companies is seeking an experienced Quality Systems Consultant to support a large-scale enterprise initiative focused on 21 CFR Part 11 compliance for a leading global life sciences organization. This is a unique opportunity to join a multi-year compliance transformation project supporting laboratory, manufacturing, and quality system modernization efforts.

We are looking for a seasoned quality professional who can quickly integrate into the organization, provide strategic guidance, and serve as a subject matter expert with minimal onboarding.

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.

Engagement Details

• Long-term consulting engagement with an anticipated duration of 18-24 months, with a strong likelihood of extension.
• Opportunity to support a highly visible, enterprise-wide compliance initiative.
• Competitive compensation commensurate with experience.
• Some travel may be required during the engagement.

If you are a Quality Systems professional with deep expertise in 21 CFR Part 11 and are looking to make a significant impact on a high-profile compliance initiative, we encourage you to apply.

This job opens for applications on 7/15/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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