Senior Director – Gxp Vendor Management and Compliance

Senior Director – Gxp Vendor Management and Compliance

Requirements

• Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred).
• Minimum of 15+ years of experience in the pharmaceutical or biotechnology industry, with at least 10 years’ experience conducting supplier audits across clinical and commercial vendors.
• Minimum of 5+ years’ experience hosting/supporting regulatory inspections (e.g., FDA, EMA, PMDA) in support of BIMO/PAI including conducting mock inspections at GMP establishments.
• Certified Quality Auditor, CQA (ASQ), ISO lead auditor or equivalent.
• Proven track record and relevant industry experience in leading supplier quality responsibilities within a global quality organization.
• Strong understanding and knowledge of global regulations (FDA, EU, ICH Q7), and other applicable regulatory guidelines.
• Excellent leadership, communication, team building and people skills, with the ability to influence stakeholders at all levels.
• Analytical thinker with a focus on continuous improvement and innovation. This role may require occasional travel (up to 20%) for quality audits, inspections, and vendor meetings.
• Flexibility to work in a fast-paced, dynamic environment with evolving priorities.

Responsibilities

• Design, develop and implement a global compliance strategy to manage GxP vendors aligned with corporate objectives, and global regulatory requirements.
• Establish a risk-based process/framework to plan, select vendors, conduct audits, qualifications, and oversight based on business impact and regulatory requirements.
• Work with RevMed GxP Quality Heads to oversee the development, implementation, and management of GxP vendors, quality systems procedures, and audits.
• Serve as the Quality lead for Quality Agreements. Draft, review and approve Technical Quality Agreement including negotiation of agreements with all major GxP vendors.
• Compile and track quality and compliance metrics (KPI) for GxP vendors and report to management on a quarterly basis.
• Lead and manage RevMed GxP audits program; develop audits schedule (annually) and conduct internal and external audits.
• Conduct quality audits of GMP vendors (clinical and commercial) to ensure compliance with RevMed procedures, Quality Agreements, and global regulations.
• Manage a team of GxP auditors (internal) and external contractors to support RevMed vendor management program.
• Prepare supplier quality audit budget annually and present to quality management.
• Support partner audits, due diligence activities and regulatory inspections at RevMed including RevMed GxP Vendors, ensuring inspection readiness and timely resolution of findings.
• Identify, assess, and mitigate GxP compliance risks including escalation of critical vendor quality events and performance to Sr. management.
• Collaborate with PDM, Clinical Operations/Development, Regulatory Affairs, GPS and other stakeholders to address GxP vendor quality events, ensure alignment on quality and compliance objectives and drive continuous improvement.
• Partner with PDM and Clinical Operations in selection of GMP and GCP vendors including managing the routine qualification activities and monitoring key KPI’s.
• Hire and manage a team of GCP and GMP auditors.
• Build, mentor, and lead a high-performing team of auditors. Provide training and development opportunities to enhance team capabilities.
• Foster a culture of quality, accountability, and collaboration within the team and across the organization.
• Stay current with global regulations and provide guidance to quality professional and cross functional teams, and to senior management, as needed.

Preferred Qualifications

• Experience managing/auditing commercial GMP vendors (DS, SDD, DP and Finished Packaging)
• Regulatory Inspection experience (host/SME)