Position: Senior Director/Director, Global Quality Assurance #2100
Location: Central, NJ
Compensation: Based upon experience
Under the guidance of the VP Quality, the Senior Director/Director of Global Clinical Quality Assurance (GCQA) will develop, implement and maintain the clinical Quality Assurance program to support global and local drug development, registration and marketing activities. This position will work in partnership with Clinical Development, Regulatory Affairs, Pharmacovigilance and other business units to ensure compliance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP).
Duties & Responsibilities:
Support the VP Quality in strategic planning of the GCQA program. Develop, implement and maintain the program to ensure compliance with domestic and international GCP/GVP regulations, the company’s policies and procedures.
Provide GCQA oversight of clinical studies to ensure compliance with the company’s and global regulatory standards.
Provide GCP guidance to clinical project teams, including risk identification/mitigation support for potential or identified operational issues or deviations, and ensures appropriate CAPA process.
Actively lead and contribute to the strategic, risk-based quality planning of GCQA audits and activities.
Lead and ensure GCQA audits are conducted in compliance with the company’s GCQA standards, ensuring corrective action implementation, and communication to relevant management/stake holders with the appropriate level of urgency.
Manage and execute the GCP/GVP audit function of vendors, investigator sites, internal and external process/systems, including databases (e.g., clinical studies and safety databases), and key deliverables (e.g., study documents, TMFs, CSRs, tables, listings, ISS, ISE).
Trend and analyze audit program results and areas of potential risk, quality issues and investigations to optimize compliance of GCP operations.
Prepare, maintain quality metrics and present trends to executive management at Quality Review meetings.
Develop and review/approve SOPs, Work Instructions, Forms, Templates and other operational documents to ensure compliance with GCP/GVP regulations.
Plan, lead, execute inspection readiness activities to ensure the company’s, investigator sites and vendors are ready for inspection by domestic and global regulatory authorities. Provide leadership and support to inspection responses, CAPA and follow-up activities.
Develop and negotiate agreements with clients and business partners to establish quality standards for activities performed through contracted and external parties.
Serve as a subject matter expert for current GCP regulations by staying informed of related quality legislation, guidance documents and industry trends.
BS/BA or advanced degree in chemistry, biology or health related equivalent with 10+ years direct experience in Clinical Quality Assurance in the pharmaceutical industry.
Direct experience leading GCP QA program and performing GCP audits of vendors, investigator sites, system and process.
In-depth knowledge of current GCP regulations, ICH requirements, EU Directives, other international regulations for clinical trials; thorough knowledge and understanding of drug development and the clinical trial process
Familiarity with current GPV and GLP regulations and requirements.
Demonstrated ability to assess risk, differentiate between critical and minor issues, and work with clinical teams to identify/implement pragmatic solutions to address them in a compliant manner.
Demonstrated ability to work independently, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
Strategic thinking, leadership skills, assertiveness, good business judgment, integrity.
Detailed oriented, with a high degree of accuracy and quality of deliverables.
Excellent oral and written communication. Strong interpersonal skills to influence and build effective business relationships with internal and external parties.
Must be able to travel to domestic and international locations approximately 25%, but may be more depending on business need and regulatory inspection activity.