Associate Director GCP/PVG Quality Assurance

The Associate Director of Quality Assurance-GCP/PVG will report to the VP of Quality. The Director of QA Good Clinical Practices (GCP)/PVG (Pharmacovigilance) will be responsible for all aspects of Quality Assurance GCP activities to ensure quality assurance and compliance of SK Life Science, Inc. (SKLSI) sponsored clinical trials with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, SKLSI Standard Operating Procedures (SOPs), and current industry standards and practices including clinical safety and post marketing pharmacovigilance activities.

Activities will generally fall under the following areas: GCP/PVG QA audit program, SKLSI quality systems, and internal/clinical study team support. The Associate Director, QA GCP/PVG will establish, maintain, and ensure effectiveness of quality programs and documentation to assure GCP/PVG compliance and inspection readiness for all clinical programs.

1. Provide/Handle an oversight on a day-to-day activity for GCP/PVG activities which includes multiple clinical studies, clinical/Post Marketing Requirements/Commitments and EAP programs.
2. Provide supervisory support to GCP/PVG QA as applicable
3. Work collaboratively with internal Clinical Operations Team to ensure compliance standards are achieved
4. Manage the GCP Quality interface and support for all Project Teams on assigned projects.
5. Identify and access compliance risk areas and develop and implement risk mitigation measures.
6. Manage GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems and study documents to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines
7. Review and approve Clinical SOPs
8. Develop and Implement Clinical QA SOPs
9. Develop and implement detailed audit plans and yearly GCP audit schedules and provide management reports on audit strategy, plans, and findings,
10. Ensure the timely and effective follow up of all identified or assigned quality issues
11. Conduct QA oversight of GCP protocols, ICFs, CSRs and other clinical trial specific documents as requested
12. Direct or perform CSR audits including systems audits EDC, IRT, PVG and eTMF audits as applicable
13. Prepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans
14. Direct and/or deliver GCP/PVG training for internal staff as applicable
15. Work closely with Clinical Development, Clinical Operations, Biostats, PVG/Safety and other departments to ensure compliance/inspection readiness
16. Provide leadership in inspection preparedness to SKLSI clinical sites, GCP and GCLP vendors for BIMO inspections and inspections by other regulatory government agencies
17. Host or participate in regulatory inspections related to GCP/PVG
18. Review and support product quality complaint/AE trends reviews and trends
19. Support process improvement initiatives; Lead continuous process improvements within Quality.
20. Maintain required knowledge of applicable regulations, guidelines and company standards and procedures.

Supervisory Experience:

Supervise GCP/PVG team members as applicable. Provide day to day support for the entire QA team, become a key contact in QA team for GCP/PVG related activities

communication with VP of QA

Provide support in managing the consultant QA as needed

BS degree or advance degree in scientific, health care or related discipline
• 10+ years of pharmaceutical experience
• Intensive GCP and PVG including process and system auditing background
• Experience with both internal and external audits
• Strong knowledge of development policies, procedures and standards (SOPs, QMS)
• Strong leadership with demonstrated ability to interface with senior leaders and different levels of organization.
• Excellent written/oral communication skills and interpersonal skills to build key networks and business relationships across all levels of the business.
• 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, and PVG systems