Are you passionate about quality and precision and looking to accelerate clinical breakthroughs in biotech?
Proclinical is working as an exclusive search partner to recruit for an Associate Director/Senior Manager for Clinical QA to oversee and manage Clinical Quality Assurance activities. This role focuses on ensuring compliance with Good Clinical Practice (GCP) standards and regulatory requirements while supporting clinical trial operations. The position offers an opportunity to lead and develop quality assurance strategies in a dynamic and evolving industry landscape.
Responsibilities:
* Implement and coordinate clinical QA activities to maintain compliance with GCP standards.
* Ensure all clinical trial activities align with GCP regulations and internal procedures.
* Develop and manage a risk-based audit program, including audits of vendors, clinical sites, and internal processes.
* Supervise and provide oversight for clinical QA consultants and third-party organizations.
* Act as the Clinical QA Lead during regulatory inspections and manage post-inspection follow-up activities.
* Monitor and report Key Performance Indicators (KPIs) related to quality metrics.
* Support additional assignments as directed by leadership.
Key Skills and Requirements:
* Strong expertise in GCP and a thorough understanding of Clinical Trial Applications (CTAs) and Investigational New Drug applications (INDs).
* In-depth knowledge of applicable regulations and industry standards.
* Proven ability to meet deadlines and manage time effectively.
* Excellent communication and collaboration skills within cross-functional teams.
* Exceptional attention to detail and organizational abilities.
* A degree in a relevant field (e.g., BSc or equivalent qualification).
* Experience in Quality Assurance, specifically GCP, within the pharmaceutical or biopharmaceutical industry.
If you are having difficulty in applying or if you have any questions, please contact Joshua 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.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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