Director Of GxP Quality

About the role

The Director of QA Compliance will lead the commercial QA Compliance function and ensure ongoing inspection readiness across audits, supplier quality, regulatory inspections, management review, and quality-related licenses. This role involves providing strategic Quality Systems oversight and collaborating cross-functionally to identify, escalate, and resolve compliance risks.

Responsibilities

• Lead QA Compliance governance and maintain continuous inspection-readiness across commercial Quality Systems.
• Manage internal, clinical, and supplier audit programs, including planning, execution, reporting, CAPA follow-up, effectiveness checks, and risk-based prioritization.
• Oversee supplier qualification, periodic review, quality agreements, performance monitoring, issue escalation, and remediation tracking.
• Serve as quality lead for regulatory inspections, involving readiness planning, hosting support, response coordination, commitment tracking, and remediation.
• Support Management Review and Quality Council forums through metrics, trend analyses, risk assessments, and executive-level compliance summaries.
• Monitor regulatory intelligence and translate global regulatory changes and enforcement trends into practical Quality System updates.
• Lead or oversee compliance activities, quality trend reviews, compliance metrics, and process improvements to enhance QMS effectiveness and scalability.

Essential Skills

• BIMO Experience
• Bachelor’s degree in life sciences, pharmacy, chemistry, biology, engineering, or a related scientific discipline; advanced degree preferred.
• 15+ years of progressive experience in Quality Assurance, Quality Compliance, or Quality Systems in pharmaceutical, biotechnology, or regulated life sciences.
• Prior leadership experience at Manager, Senior Manager, Associate Director, or Director level in commercial Quality Systems or QA Compliance programs.
• Experience with commercial-stage quality systems including audits, management review, metrics, inspection readiness, and supplier oversight.
• Working knowledge of FDA, EMA, PMDA preferred.
• Familiarity with ICH, GxP, GMP, GCP, and commercial quality requirements, focusing on inspection support and regulatory submission QC/Support.
• Excellent written and verbal communication skills, with the ability to present complex compliance topics to Senior leaders and cross-functional stakeholders.

Work Environment

This position is remote, with a preference for candidates located on the East Coast, but flexibility is available for highly qualified individuals. The role offers an opportunity to lead and develop a commercial QA Compliance function with broad ownership across audit programs, supplier quality, inspection readiness, and management review. It is a high-visibility leadership role with exposure to Senior stakeholders, cross-functional partners, and regulated third-party networks.

Pay

The pay range for this position is $125.00 – $135.00/hr. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)