Senior Director, Quality & Compliance

Precision Medicine Group

Job Overview

Location

Remote, United States

Job Type

Full-time

Full Job Description

📋 Description

• The Senior Director, Quality & Compliance provides strategic and operational leadership for clinical quality assurance to ensure studies are planned, conducted, documented, and reported in compliance with global regulations (ICH E6 GCP), sponsor requirements, and Precision procedures.
• Day-to-day responsibilities include leading GCP quality assurance programs, conducting audits (site, vendor, internal process, TMF), managing QMS and CAPA processes, overseeing quality events and deviations, supporting health authority inspections, providing GCP training, mentoring QA staff, and advising cross-functional teams on compliance and data integrity.
• Precision Medicine Group is a remote-first organization focused on delivering clinical development and commercialization services to biopharma clients, with a strong emphasis on quality, regulatory compliance, and data integrity across global operations.
• In this role, the individual will deepen expertise in global GCP and regulatory frameworks, lead and develop high-performing QA teams, drive continuous improvement in quality systems, and serve as a trusted advisor to internal stakeholders and external clients on inspection readiness and compliance strategy.

🎯 Requirements

• 10+ years of experience in GCP Quality Assurance within a CRO, biotechnology, or pharmaceutical industry
• Bachelor’s degree in life sciences or a related scientific field (advanced degree preferred)
• Demonstrated experience conducting and leading GCP audits across clinical sites, internal processes, TMF, and vendor qualification
• Strong knowledge of FDA, EMA, and ICH regulations, including global GCP guidelines
• Experience supporting regulatory inspections and inspection readiness activities
• Strong leadership and communication skills with ability to work cross-functionally across clinical and nonclinical teams

🏖️ Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation

Skills & Technologies

GCP

Senior

Remote

Degree Required

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Precision Medicine Group

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About Precision Medicine Group

Precision Medicine Group (PMG) is a leading life sciences consulting firm dedicated to accelerating the development and commercialization of precision medicine. They offer a comprehensive suite of services, including strategy, market access, regulatory affairs, and commercialization support. PMG partners with pharmaceutical, biotechnology, and diagnostic companies to navigate the complex landscape of personalized healthcare. Their expertise spans various therapeutic areas and advanced molecular technologies. By leveraging deep scientific knowledge and market insights, PMG helps clients optimize their drug development pipelines, secure regulatory approvals, and successfully launch innovative therapies. They are committed to advancing patient care through the power of precision medicine, ensuring that the right treatments reach the right patients at the right time.

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