Assistant Director QA GCP/GVP

For a mid sized pharma company we are seeking an Assistant Director / Associate Director, Development Quality Assurance for QA GCP/GVP to work remotely with 40-50% travel associated.

RESPONSIBILITIES:

• Conduct and/or coordinate internal and external (both domestic and international) GCP & GVP audits.

• Lead/perform for-cause audits or other high-profile audits, projects, and/or special investigations to evaluate non-compliance, root cause identification, and report results to leadershipLeads and/or supports global regulatory agency inspections (end to end) and other audits.

• Ensure creation/maintenance of documents for pre-inspection preparation

• Oversee/conduct/coordinate training for defined SMEs and ensure setup of pre-inspection preparation meetings for line unit heads and appropriate staff

• Lead/contribute to the assessment of reports and results from Health Authority inspections. Including the associated risks and recommendations, for provision to relevant leadership

REQUIREMENTS:

• Bachelor and/or Masters degree (healthcare and/or scientific-related discipline is highly desirable).

• Minimum 6-10 years of GCP and/or GVP quality assurance experience in a pharmaceuticals or biotechnology industry.

• Demonstrated track record of both GCP and GVP auditing experience

• Good understanding of end to end clinical development process, including post marketing studies (e.g., PASS).

• Thorough understanding of regulatory requirements governing GCP and GVP, including EU regulations.