Associate Director of Quality Assurance (GCP)
PRIMARY OBJECTIVE OF THE POSITION:
The primary objective of the Assoc. Director of Quality Assurance is to insure GxP (i.e. GCP, GLP, etc.) and internal SOP compliance as required for clinical and drug development related internal processes, tools, and study records, and to monitor, measure, track and communicate nonconformance to enable appropriate corrective actions. Creation of continuous improvement processes and best practices is also required to maximize productivity and efficiency within and between functional departments.
The ideal candidate will have a Bachelor’s degree and five to seven years of experience in clinical research quality assurance (all aspects), with 5 or more years in systems QA with a deep understanding of flexible and value-added QA processes and implementations thereof. Drug development lifecycle experience is highly desired. Qualified candidate should possess a strong knowledge of Good Clinical Practices (FDA and ICH), a good understanding of 21CFR Part 11 with respect to clinical processes and systems, including database and eCRF validation procedures, eCTD Quality Assurance, and the ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner. Ability to proactively and indirectly manage and influence in a matrix environment within TI is required as is hands-on integration with functional processes. Some GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) experience is also highly desirable. Attention to detail as well as a crisp, clear and concise style in written and oral communications is required.
MAJOR RESPONSIBILITIES AND DUTIES:
The responsibilities of the Assoc. Director of Quality Assurance include:
- Maintain an effective, living Quality Management System which will include the conduct of internal and external audits of drug development related study records and processes to assure compliance with regulatory requirements and company SOPs.
- Develop metrics for QA activities and observations that will form the basis for continuous improvement practices and processes. Own the measurement and corrective action process in concert with line functional management.
- Develop a document control system and provide training on its use.
- Lead the efforts in continuous improvement of all QA related activities to increase efficiencies and reduce redundancies. Streamline redundancies and reduce document/form cycle requirements as appropriate.
- Author SOP’s and integrate with functional departments as assigned to broaden QA impact.
- Work with department heads to identify, improve, and resolve quality-related issues as identified via audits, SOP reviews, rework, etc.
- Perform compliance audits, Investigator Site and in-house clinical file audits.
- Perform systems and process audits of vendors. Work with functional departments to identify, qualify, and maintain TI’s vendor files. Own the vendor qualification process, compliance, and files.
- Develop, maintain and manage company polices, SOPs and associated processes and procedures.
- Maintain records of employee training on policies, SOPs, and associated processes and procedures, and communicate with department heads when updates are needed.
- Provide QA for databases, clinical study reports, regulatory submissions, etc. Assure source traceability throughout the process. Identify and resolve gaps and inefficiencies with line functional management.
- Assist with the preparation and submission of regulatory documents including but not limited to correspondence, briefing packets, IND/NDA applications, and amendments/supplements.
- Participate in the development of QA strategies for projects and programs.
- Provide support for business development activities as required.
- Assist with non-clinical pharmacology and toxicology, and chemistry manufacturing and control study quality assurance activities. Cross train on assigned areas to insure TI depth of resources.