SK Life Science, Inc. · 21 hours ago
Associate Director GCP/PVG Quality Assurance
US-NJ-Paramus
Full-time
Onsite
Lead/Staff, Director/Executive
10+ years expSK Life Science, Inc. is a pharmaceutical company seeking an Associate Director of Quality Assurance-GCP/PVG. The role involves ensuring quality assurance and compliance for clinical trials, overseeing GCP/PVG activities, and managing quality programs to maintain compliance and readiness for inspections.
BiotechnologyPharmaceutical
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 applicable
Work collaboratively with internal Clinical Operations Team to ensure compliance standards are achieved
Manage 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 guidelines
Review and approve Clinical SOPs
Develop and Implement Clinical QA SOPs
Develop and implement detailed audit plans and yearly GCP audit schedules and provide management reports on audit strategy, plans, and findings
Ensure the timely and effective follow up of all identified or assigned quality issues
Conduct QA oversight of GCP protocols, ICFs, CSRs and other clinical trial specific documents as requested
Direct or perform CSR audits including systems audits EDC, IRT, PVG and eTMF audits as applicable
Prepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans
Direct and/or deliver GCP/PVG training for internal staff as applicable
Work closely with Clinical Development, Clinical Operations, Biostats, PVG/Safety and other departments to ensure compliance/inspection readiness
Provide leadership in inspection preparedness to SKLSI clinical sites, GCP and GCLP vendors for BIMO inspections and inspections by other regulatory government agencies
Host or participate in regulatory inspections related to GCP/PVG
Review and support product quality complaint/AE trends reviews and trends
Support process improvement initiatives; Lead continuous process improvements within Quality
Maintain required knowledge of applicable regulations, guidelines and company standards and procedures
Qualification
Required
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
Company
SK Life Science, Inc.
SK Life Science, Inc., a U.S. subsidiary of SK Biopharmaceuticals, stands at the forefront of innovation in healthcare.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Hong-Wook Kim
Vice President & Chief Operating Officer
Christine Mapes
CMO Manager, Supply Chain
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