Manager, Quality Assurance & Compliance
The Manager Quality Assurance/Compliance (MQAC) contributes to the design, implementation and maintenance of a QA system for CCSA. This system supports both internal CCSA needs and ensures compliance with clients’ projects requirements. These projects encompass a variety of services to government, academic, and commercial clients including statistical design of clinical trials and research studies, data management, data analysis and reporting, regulatory affairs, site monitoring, safety/medical monitoring, document management, and site and vendor management. The MQAC implements corporate QA processes for standard operating procedures (SOPs), staff training, and corrective/preventative actions within the context of the projects, as well as contributes to the development of specific QA programs that address the needs of each client. The MQAC will develop a system for the projects to define and track relevant performance, quality, and risk metrics. The MQAC will interact with the CCSA departments, project managers and other staff to accomplish the objectives of the QA system. The MQAC reports to the President, CEO within the Executive Office and works closely with the President, CEO, making observations, findings and recommendations for process improvement and targeted training.
Essential Duties and Responsibilities:
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
- Knowledgeable of and stays up-to-date with industry and regulatory agency quality regulations.
- Serve as a QA resource providing QA technical guidance recommendations to departments; Provides GCP QA expertise and leadership.
- Develops and maintains QA programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines.
- Participates, develops, and implements SOPs to ensure CCSA’s Quality Management Programs compliance. Updates and implements changes as required.
- Oversees quality control review of regulatory documents and processes.
- Adheres to regulatory submission processes in accordance with required company/project guidelines.
- Leads compliance audits as required.
- Works with stakeholders to ensure that audits are conducted on a continuing basis to enforce company and client requirements.
- Ensures compliance with current GxP (particularly GLP and GCP) practices. Maintains International Conference on Harmonization (ICH)/Good Clinical Practice (GCP)/Good Laboratory Practice (GLP) audits. Working knowledge of 21 CFR Parts 11 and 58 as part of product development processes.
- Manages and monitors corrective action plans.
- Works with the internal stakeholders to ensure appropriate and timely response and follow-up on QAC matters.
- Develops and maintains manual of operations (MOP) using company/client standards and requirements.
- Provides training in quality and reliability procedures, as needed, and acts as a resource to ensure QC.
- Develops and oversees on-site audit visits in accordance with clients’ requirements.
Decision Making Responsibility:
- Makes decisions independently with input from department directors, President, CEO and others in the Executive Office.
- Demonstrates excellent verbal, written and interpersonal communication skills.
- Demonstrates knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, and performance measures and quality improvement.
- Certification by ASQ (Certified Quality Auditor, Certified Quality Manager) or other industry-recognized professional organizations is a plus.
- Ability to work with cross functional groups and handle difficult people/situations under pressure.
- Ability to communicate clear and accurate audit observations based on regulatory requirements and best practice, which gains acceptance from auditees.
- Ability to deal with competing timelines.
- Ability to work independently and as part of a team.
- Ability to prioritize work and handle multiple assignments.
- Excellent decision-making skills to manage workload.
- ≥5 years’ experience as Senior QA Specialist or in comparable position in relevant work setting.
- BA or BS in biological sciences, chemistry, or related field.