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Job type: Permanent

Discipline: Good Clinical Practice (GCP)

Location: United States

The Director's - Permanent - New Jersey (Hybrid)

̽��ϼ� is seeking a Director of Clinical Quality Assurance (GCP) to lead the design, delivery, and execution of clinical quality assurance strategies in the US. This role focuses on Good Clinical Practice (GCP) oversight, ensuring compliance with internal policies, standard operating procedures (SOPs), and global regulatory guidelines.

Primary Responsibilities:

The successful candidate will require a proactive approach to audit and inspection management, quality system oversight, and fostering innovation within clinical quality programs. This hybrid role requires at least two days per week onsite in Nutley, NJ.

Skills & Requirements:

Bachelor's degree in a relevant discipline; advanced degree preferred.
Experience in clinical research, operations, or data management, with expertise in GCP auditing.
Strong knowledge of US, EU, and international regulatory standards for clinical trials.
Proven ability to manage inspections and influence decision-making processes.
Effective communication and report-writing skills.
Experience supervising employees and managing cross-cultural differences.
Familiarity with data integrity controls, GxP systems, and computer system validation.
Analytical skills to conduct routine and complex audits independently.
Ability to travel approximately 15%.

The Director's responsibilities will be:

Conduct audits independently, including study sites, clinical vendors, and internal processes.
Oversee and review results of clinical quality assurance audits.
Facilitate sponsor health authority inspections for global clinical facilities and study sites.
Drive innovation by evaluating and implementing new technologies and procedures across clinical quality programs.
Develop and execute skill-building initiatives for CQA staff through cross-functional and external partnerships.
Manage direct reports, including goal setting, performance management, and professional development.

Compensation:

$200 000.00 - $250 000.00 Per Annum

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

̽��ϼ� is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ̽��ϼ� is acting as an Employment Agency in relation to this vacancy.

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