Manager of Quality Assurance
PRIMARY OBJECTIVE OF THE POSITION:
The primary role of the Manager of Quality Assurance position is to provide technical and administrative support to the QA Department by ensuring that all the company’s quality systems (employee training, internal audits, vendor management, SOPs, and deviation management) are being maintained in a timely manner. Another objective is to ensure GxP (i.e. GCP, GLP, etc.) compliance as required for drug development- and clinical trial-related internal processes, tools, and study records, and to monitor, measure, track and communicate nonconformance(s) to enable appropriate corrective action(s).
The ideal candidate will have a Bachelor’s degree and three to five years of experience in Quality Assurance, QA compliance, or clinical research quality assurance. Drug development-lifecycle experience is highly desirable. The Manager of Quality Assurance should possess a strong knowledge of Good Clinical Practices (FDA and ICH), a good understanding of 21CFR Part 11, and the ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner. 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 Manager of Quality Assurance include:
- Maintain an effective Quality Management System, which will include the conduct of internal and external audits of drug development- and clinical trial-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. Participate in the management of the company’s SOP deviation and CAPA systems.
- 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.
- Author SOPs 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 File audits 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.
- Maintain records of employee training on policies, SOPs, and associated processes and procedures, and communicate with department heads when updates are needed. Participate in the management of employee training record archiving using the company’s learning management system (LMS).
- Review databases, clinical study reports, regulatory submissions, etc. Participate in the development of QA strategies for projects and programs.
- Provide support for business development activities as required.
- Assist with a variety of quality assurance activities. Cross train on assigned areas to insure TI depth of resources.