Overview:

The Director, CQA will be a critical team member who designs and implements risk-based Clinical Practice (GCP), Good Laboratory Practice (GLP) Good Clinical Laboratory Practice (GCLP) and Good Pharmacovigilance Practice (GVP) audit programs and compliance oversight. This person will be responsible for activities that include assessing the effectiveness of GC, GLP, GCLP, and GVP processes, creating and presenting actionable reports, presenting data to Senior Management, and leading and supporting components of Health Authority inspections.

Principle Responsibilities and Duties:

• Directly interface with Clinical Development, Clinical Operations, Translational and Development, Pharmacovigilance, and other supporting areas for GCP audits of internal processes.
• Promote collaboration to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines.
• Ensures appropriate corrective and preventive actions (CAPAs) are completed in a timely manner. As appropriate escalates issues of critical noncompliance and/or lack of urgency in remediation to senior management and appropriate internal R&D functions.
• Develops and executes a quality governance and oversight program of clinical vendors and monitors vendor quality performance metrics.
• Consults with other R&D functions in developing appropriate vendor quality oversight and inspection preparation plans. Conduct or make assignments for audits (on-site and/or remote) of Clinical Service Providers (e.g. Laboratories, Phase I Units/Clinical Pharmacology Units (CPUs), Bioanalytical Laboratories, Clinical Investigator sites and internal processes.) Review and evaluate key clinical system validation/qualification packages for completeness, accuracy, and compliance with the clients and relevant Regulatory requirements.
• Mentor other Clinical Quality Operations Quality personnel and contractors; may have supervisory responsibilities within Quality Assurance Unit.
• Conduct or lead GCP, GLP, GCLP, and GPVP training and education in accordance with global GCP standards.
• Develop risk-based recommendations for prioritization of risks and appropriate corrective/preventative actions.
• Author, revise, and implement CQA written procedures.
• Drive preparation activities for GCP, GLP, GCLP, and GVP Health Authority inspections to assure successful outcomes of the inspections from conduct through the coordination of responses.
• Ensure follow-up on all inspection commitments, post-inspection activities, corrective and preventative actions, and resolve all conflicts for timely closure.
• Support CQA projects.
• Provide administrative support including maintaining audit logs, generating reports, creating templates and others as needed.

Additional Competencies, Knowledge and Skill Requirements

• Expert knowledge of regulatory authority inspection practices internally, externally, domestic and internationally
• Extensive experience managing and supporting regulatory authority inspections of clinical research activities
• Extensive leadership experience and mentoring skills to ensure all the clients team members have a firm understanding of the clients inspection process
• Thorough knowledge and application of international requirements of GCP, GLP, GCLP, GVP, and relevant ICH Guidelines

Experience, Education, Training, Traits:

• BS degree in a scientific field.
• 12 years or greater experience in a Biotechnology/Pharmaceutical CQA role with at least 10 years CQA auditing experience.
• Strong knowledge of global GCP, GLP, GCLP, and GPVP regulations and standards.
• Experience with Health Authority Inspections
• Excellent collaboration skills.
• Ability to work independently.
• Excellent verbal and written communication skills.
• Demonstrated ability to effectively organize and execute tasks.
• Computer proficiency with Word, Excel, and PowerPoint.
• Ability to work in a fast-paced, dynamic environment.
• Must be able to travel up to 30% time