Life Science Consulting Opportunities

Compliance Architects is actively seeking exceptional, highly-experienced independent consultants with deep skills and expertise in life sciences’ quality, regulatory and compliance to help drive innovation and improved outcomes with our portfolio of leading life science clients.  We’re looking for individuals with varying and diverse expertise (regulatory, clinical, GxP, pharmaceuticals, medical devices, biologics, dietary supplements, etc.) […]

Managing FDA Quality / Compliance Consultant

Position Information: Senior Quality Assurance/Compliance strategist with 20+ years of experience across regulated product classes including pharmaceuticals, medical devices and biologics. Ability to work with clients to develop quality, compliance and regulatory strategies for compliance with FDA requirements and expectations. Demonstrated accomplishments in: Quality systems assessment – design control, systems development and implementation, ISO 13485/Quality System […]

Quality System Remediation Program Manager

Position information: Experienced consultant(s) needed for large project and program management assignments across FDA- regulated product classes including pharmaceuticals, medical devices and biologics.  Core responsibility is to work with internal client executives and staff to help drive and manage project objectives in accordance with FDA requirements and expectations. Demonstrated experiences/accomplishments should include: Large, complex program […]

Senior FDA Quality / Compliance Consultant

Opportunity Information: Senior manufacturing, quality and regulatory professional with 20+ years of experience across regulated product classes including pharmaceuticals and medical device. Strong project leadership abilities necessary to work with clients to develop quality assurance and regulatory strategies for compliance with FDA regulations. Demonstrated accomplishments in: Quality System development, enhancement, and harmonization Quality System assessments, audits […]

Regulated Applications Consultant

Senior regulated industry applications IT professional with 20+ years of quality and compliance experience including principles of software quality assurance, software validation, information security and 21 CFR Part 11. Familiar with all aspects of quality system business processes and FDA-regulated manufacturing and laboratory operations.   Demonstrated accomplishments in: SAP configuration and software validation principles including, but […]