Director of Clinical Quality Assurance (GCP)
Are you a seasoned clinical quality assurance professional with a passion for global impact? We are seeking a dynamic and experienced individual to lead our Quality Assurance team as the Director of Clinical Quality Assurance. Join us on our mission to ensure the highest standards of quality and compliance across our diverse operations.
- Develop and implement a global quality assurance strategy aligned with organisational goals.
- Lead, inspire and develop a team of quality professionals, fostering a culture of excellence and continuous improvement.
- Ensure compliance with international GxP regulations and standards with particular focus on Good Clinical Practice (GCP), overseeing the implementation of quality management systems.
- Work closely with cross-functional teams, including, Clinical Operations to integrate quality into all aspects of product development and lifecycle.
- Identify opportunities for process improvements and implement best practices to enhance efficiency and effectiveness.
- Drive a culture of quality by championing adherence to Good Clinical Practices (GCP) and other relevant quality standards.
Audits and Inspections:
- Lead and manage international GCP audits and inspections, ensuring preparedness and timely resolution of findings.
- Develop and maintain strong relationships with regulatory authorities, ensuring open communication and transparency.
Data-Driven Decision Making:
- Utilise data analytics and metrics to monitor and assess the effectiveness of quality systems, driving data-driven decision-making processes.
Bachelor’s degree in a relevant scientific or healthcare field; advanced degree (master’s or Ph.D.) preferred
Extensive experience in clinical quality assurance (minimum of 8-10 years) within the pharmaceutical or biotechnology industries.
Proven leadership experience with a global mindset
In-depth knowledge of GCP, regulatory requirements, and industry best practices
Strong communication and interpersonal skills, with the ability to collaborate across functions and cultures.
A strategic thinker with a proactive approach to problem-solving.
Why Join Us:
PHARMExcel is a leading Contract Research Organisation (CRO) dedicated to enabling successful clinical trial delivery by combining collaboration, quality, expertise and passion.
We are not afraid to challenge the status quo to achieve better outcomes for our sponsors and patients, as they remain at the heart of what we do.
If you’re ready to take on a leadership role and help us shape the future of global clinical quality assurance, and grow our quality team, we invite you to apply! Join us in our pursuit of excellence and innovation.
Competitive compensation package and comprehensive benefits.
Professional development opportunities and a supportive, collaborative work environment.
Submit your CV and a cover letter detailing your relevant experience and accomplishments to email@example.com.
Deadline for applications: 09 Feb 2024.
F2F Interviews scheduled for 13th and 14th of Feb at our main offices in Hertfordshire.
We look forward to welcoming you to our clinical quality assurance team!