Associate Director - Clinical Quality Assurance

Associate Director - Clinical Quality Assurance

This position will focus on implementation of the global clinical QA audit program to assess cGCP compliance.

Key accountabilities: Champion GCP compliance improvement initiatives
Manage compliance audit programs and due diligence activities
In collaboration with other management peers, analyze audit results and report findings to senior management
Oversee departmental budget and operations (10+ personnel)
Act as a Clinical QA resource to management peers and executive management
Recruit new department staff as required
Provide training and mentoring of departmental staff and consultation for external peers as needed
Facilitate in-house regulatory compliance audits as required
Maintain positive relationships with international collaborators
REQUIREMENTS
Qualifications AND Requirements: BS or MS degree in life sciences or an RN
10+ years of clinical trial experience
5+ years of management experience in a audit or clinical QA compliance department
Expert knowledge in Good Clinical Practice (GCP) (US and international)
Audit program implementation experience including interpreting regulations, guidelines, and compliance issues
Drug development, drug application and approval process experience
Good administrative skills including budget management and departmental operations
Strong leadership and mentoring capabilities to support compliance teams.
Excellent communication skills and organizational skills
Availability for travel (approximately 10%)

If interested and you meet the stated position requirements, please send your resume in MS WORD (DOC file attachment) format to: [Click here for email]

Please note: Resumes in PDF, WPS, or other non-conforming formats will not be accepted. Resumes not meeting the required experience will not be acknowledged.