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.
#LI-KP1 #LI-ONSITE