Director, GCP Quality

SUMMARY:

The Director, QA Good Clinical Practices (GCP) will be responsible for all aspects of Quality Assurance for GCP activities to ensure quality  and compliance of Surface sponsored clinical trials with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, Surface Standard Operating Procedures (SOPs), and current industry standards and practices. Activities will generally fall under the following areas: GCP QA audit program, Surface quality systems, and internal/clinical study team support. The Director, QA GCP will establish, maintain, and ensure effectiveness of quality programs and documentation to assure GCP compliance and inspection readiness.

RESPONSIBILITIES:

Quality Standards/Compliance/Risk

• Develop standards and partner with Clinical Operations, Regulatory, Pharmacovigilance, Data Management, Clinical Development, Clinical Supply Operations, Clinical Pharmacology and other functions to establish and/or improve risk-based GCP processes and procedures
• Develop, review, contribute to and/or implement GCP controlled procedures and provide GCP input for the development of quality systems, as needed
• Direct and/or deliver yearly GCP training for internal staff
• Identify risks and areas for improvement to leadership and develop/ implement risk mitigation measures.
• Perform risk-based quality assessments and remediation, as needed
• Track and report Key Performance Indicators to Head of Quality

Non-Compliance

• Serve as the expert GCP quality advisor for deviation and non-compliance management & escalation, with a focus on critical and major quality events
  • Track GCP deviations, facilitate investigations, and work with stakeholders to plan and track CAPAs, including external service providers
• Assist resolving compliance issues internally and at clinical sites, clinical vendors, and laboratories; and provide assessment of the impact of any deficiencies

Management of External Activities

• Establish relationship with external vendors’ quality organization and ensure appropriate escalation of quality issues to Surface Quality.
• Collaborate with GMP Quality for external activities associated with manufacturing, disposition, and distribution of clinical materials
• Monitor performance of vendors to evaluate and mitigate program and compliance risk(s) and escalating quality issues as needed
• Interface with internal departments and external vendors on a variety of technical/quality subjects
• Ensure appropriate qualification of vendors and monitor ongoing compliance

Quality Plan/Audit

• Develop and Manage GCP quality/audit plan to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and internal audits.  The associated areas of responsibility will include the completion and/or oversight of the following:
  • Generation of the annual quality/audit plan and schedule for each clinical program in collaboration with internal clinical groups
  • Ensure the quality/audit plan and status updates are reviewed with the Head of Quality and internal customers
  • Direct or perform internal and external audits (including eTMF and study audits )in accordance with the quality/audit plan.  This includes generation and/or review of audit agendas, reports and follow up activities.
  • Ensure any critical issues are escalated to the Head of Quality
  • Author or review written audit reports and communicate findings and recommendations and evaluate  the adequacy and completeness of corrective and preventative action plans
  • Ensure the timely and effective follow up of all identified or assigned quality issues

Regulatory Submissions/Inspection

• Participate in preparation, conduct, and post-Inspection activities related to regulatory inspections, which may include reviewing Inspection Readiness Planning, Mock Inspections, and risk-based management of program inspection quality events
• Provide leadership for regulatory agency inspection preparedness for Surface including but not limited internal GCP functions, clinical site support and, GCP and GLP vendors

EDUCATION AND EXPERIENCE: 

• Bachelor’s Degree or advanced degree in a scientific discipline; Quality assurance professional certification is a plus.
• Minimum of 10+ years’ current work experience in pharmaceutical industry Quality Assurance required.
• Demonstrated Quality Management System experience (GCP specific QMS experience preferred).
• Demonstrated Issue Management and CAPA experience in a clinical environment. Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.
• Strong leadership with demonstrated ability to interface with senior leaders and different levels of organization.
• Solid understanding of GCP, GLP and ICH clinical requirements.
• Excellent written/oral communication skills and interpersonal skills to build key networks and business relationships across all levels of the business.
• Attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents.
• A self-starter and a team-player who thrives in a fast-paced dynamic team environment. Knowledge of Microsoft Office applications, Adobe, DocuSign, and Veeva.
• Experienced working with EDC, IRT, eTMF, EMR systems.
• Potential for domestic and international travel up to 10% of time