Associate Director GCP/PVG Quality Assurance
Job in
Paramus, Bergen County, New Jersey, 07653, USA
Listing for:
SK Life Science
Full Time
position
Listed on 2026-02-01
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Salary/Wage Range or Industry Benchmark: 200000 - 250000 USD Yearly
USD
200000.00
250000.00
YEAR
Job Description & How to Apply Below
Overview
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.
Responsibilities
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.Provide supervisory support to GCP/PVG QA as applicableWork collaboratively with internal Clinical Operations Team to ensure compliance standards are achievedManage the GCP Quality interface and support for all Project Teams on assigned projects.Identify and access compliance risk areas and develop and implement risk mitigation measures.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 guidelinesReview and approve Clinical SOPsDevelop and Implement Clinical QA SOPsDevelop and implement detailed audit plans and yearly GCP audit schedules and provide management reports on audit strategy, plans, and findingsEnsure the timely and effective follow up of all identified or assigned quality issuesConduct QA oversight of GCP protocols, ICFs, CSRs and other clinical trial specific documents as requestedDirect or perform CSR audits including systems audits EDC, IRT, PVG and eTMF audits as applicablePrepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plansDirect and/or deliver GCP/PVG training for internal staff as applicableWork closely with Clinical Development, Clinical Operations, Biostats, PVG/Safety and other departments to ensure compliance/inspection readinessProvide leadership in inspection preparedness to SKLSI clinical sites, GCP and GCLP vendors for BIMO inspections and inspections by other regulatory government agenciesHost or participate in regulatory inspections related to GCP/PVGReview and support product quality complaint/AE trends reviews and trendsSupport process improvement initiatives;
Lead continuous process improvements within Quality.Maintain required knowledge of applicable regulations, guidelines and company standards and procedures.Supervisory Experience: Supervises 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, and provide support in managing the consultant QA as needed.
Qualifications
- 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, Docu Sign, and Veeva.
- Experienced working with EDC, IRT, eTMF, and PVG systems
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Position Requirements
10+ Years
work experience
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