A clinical-stage biopharma company is seeking an Associate Director, Clinical Quality Assurance to support its global GxP compliance and inspection readiness efforts. This hybrid role, based in Lexington, MA, will lead the development of quality systems and manage clinical audit activities to ensure alignment with international regulatory standards and inspection preparedness.

Key Responsibilities

• Oversee GCP quality systems and lead inspection readiness programs
• Conduct audits of clinical sites, vendors, and internal processes
• Develop and maintain SOPs to ensure GxP compliance
• Advise internal teams on regulatory requirements and inspection planning
• Drive continuous improvement across QA processes and systems

Requirements

• 7+ years of experience in pharma/biotech QA; 1+ year in leadership
• Strong understanding of GCP, GMP, and GVP regulations
• Experience managing CROs and participating in regulatory inspections
• Scientific degree required; advanced degree preferred
• Excellent communication and stakeholder management skills

For more information, do get in touch with [email protected]

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LSR is a privately owned and independent recruitment company focused on the Life Sciences industry. We are a subsidiary of Morgan Prestwich (MP), Europe's leading boutique Life Sciences executive search and advisory firm.

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