New York City (Manhattan), New York
Senior Director Clinical Quality Assurance
Summary: The Senior Director of Good Clinical Practice (GCP)/Good Laboratory Practice (GLP) Quality Assurance (QA) A will develop, implement and maintain the Clinical QA (CQA) 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 GCP/GLP regulations.
· Works with both internal staff and external stakeholders to promote understanding of clinical and pre-clinical Quality activities and objectives within the company, and prioritizes departmental projects according to OVID senior staff and departmental goals.
· Provide GCP guidance to clinical project teams, including risk identification/mitigation support for potential or identified operational issues or deviations, and ensures appropriate Corrective and Preventive Action (CAPA) process.
· Maintain a current working knowledge of the US GLP/GCP requirements, industry practices, International Conference on Harmonisation (ICH) Guidelines, internal policies and procedures that affect regulatory compliance.
· Assures the training and continuing education of staff regarding GCP/GLP regulatory requirements and guidelines.
· Develop, implement and maintain the program to ensure compliance with domestic and international GCP/GLP regulations, and OVID policies and procedures.
· As the QA representative on pre-clinical/clinical project team, provide GCP/GLP oversight of clinical studies to ensure compliance with OVID 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 GCP/GLP audits and activities.
· Lead and/or ensure GCP/GLP audits are conducted in compliance with OVID GCP/GLP standards, ensuring corrective action implementation, and communication to relevant management/stake holders with the appropriate level of urgency.
· Manage and/or execute the GCP/GLP audit function of vendors, investigator sites, internal and external process/systems.
· Trend and analyze audit program results and areas of potential risk, quality issues and investigations to optimize compliance of GCP operations.
· Plan, lead, execute inspection readiness activities to ensure Ovid, 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.
· Review and approve clinical material packaging and labelling.
· Participate in in the development, implementation and maintenance of OVID’s policies and Standard Operating Procedures (SOPs).
· Provide SOP and/or GCP training to OVID employees on an as-needed basis.
· BS/BA and a minimum of 10+ years of relevant experience in CQA required.
· 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 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.
· Provide strategic thinking, leadership, assertiveness, good business judgment and integrity in all activities.
· Detail oriented, with a high degree of accuracy and quality of deliverables.
· Excellent oral and written communication. Strong interpersonal skills with ability to influence and build effective business relationships with internal and external parties.
· Must be able to travel to domestic and international locations approximately 25 percent, (post-pandemic) but may be more depending on business need and regulatory inspection activity.
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