Associate Director GCP/GVP

Associate Director GCP/GVP Clinical Quality Assurance

Paramus, New Jersey (Hybrid)

$175,000-$195,000

Job Description

EPM is partnered with a very exciting commercial stage biotechnology company that is focused on changing the landscape of Neuropsychiatric and CNS disorders. With a drug that is already approved on the market with potential to be a blockbuster, they have ample revenue coming in while still developing 8 new assets. Several of those are in Phase 3 now with a high chance of success, giving you the opportunity to join at a very exciting time. This is a very high potential opportunity with not only room for financial benefits, but tons of room for professional growth and organic vertical mobility. If you want to join a company that has the stability of large pharma, but the opportunity of small biotech, apply now.

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.

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, DocuSign, and Veeva.
• Experienced working with EDC, IRT, eTMF, and PVG systems

Benefits

• Bonus
• Equity
• Healthcare
• PTO