Executive Director, Global Clinical QA

Executive Director of Global Clinical Quality Assurance - Permanent - NJ

Proclinical is seeking a dedicated and innovative Executive Director to head up the department of Global Clinical Quality Assurance.

Primary Responsibilities :

The successful candidate will be required to lead the global quality assurance strategy, ensuring compliance with Good Clinical Practice (GCP) and regulatory standards.

This role focuses on managing US and international audits and inspections, maintaining the highest quality standards in clinical research.

Skills & Requirements :

• Bachelor's degree in Life Sciences, Pharmacy, or related field. An advanced degree (MS or PhD) is preferred.
• Extensive experience in clinical quality assurance within a global organization, including GCP-focused work and managing international audits and inspections.
• Certification in Quality Assurance such as CQA or RQAP-GCP preferred.
• Experience with PV Quality and in oncology trials is preferred.
• Extensive knowledge of ICH GCP and relevant global regulations and guidelines along with knowledge of GCP, FDA and EMA.
• Experience interacting with inspectors and cross-functional, global teams.
• Exceptional leadership and organizational skills.
• Strong analytical skills and a methodical approach to problem resolution.
• Excellent communication skills, capable of effectively presenting and discussing complex issues to influence outcomes.
• Strong project management skills and demonstrated ability to look at the big picture when making decisions.
• Attention to detail with an ability to perform critical review of various types of documents.
• Ability to independently solve problems and facilitate resolution of issues.
• Ability to travel globally 15% as needed to office locations and for business meetings.

The Executive Director of Global Clinical QA's responsibilities will be :

• Develop and implement global quality assurance policies and procedures that comply with GCP and regulatory requirements across different regions.
• Lead and manage comprehensive audit programs, including both routine and for-cause audits, to ensure adherence to GCP and regulatory compliance.
• Oversee preparation and response strategies for both US and ex-US regulatory inspections.
• Collaborate with regulatory affairs and clinical operations to align quality assurance strategies with overall clinical development plans.
• Ensure continuous update and adaptation of quality processes to reflect changes in regulatory standards and best practices.
• Serve as the primary quality assurance liaison with regulatory authorities, partners, and internal stakeholders.
• Ensure transparent communication and collaboration on quality-related matters.
17 days ago