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Director, Clinical Quality Assurance
4 months ago
Proclinical is seeking a dedicated and experienced Director of Clinical Quality. This role is pivotal in developing and implementing quality assurance strategies that support our clinical portfolio. The successful candidate will be responsible for establishing effective GCP QA audit programs and systems that support clinical trials. This role can be home-based within the United Kingdom or can be a hybrid working role or full office working role within the London office.
Responsibilities:
- Develop and implement GCP risk-based processes and frameworks for vendor and system oversight
- Define and build the GCP QA strategy to support our clinical portfolio
- Develop and deliver ongoing GCP training
- Establish processes and procedures for the GCP audit program
- Manage audits of sites, documents, databases, vendors, or internal systems in compliance with GCP and quality standards
- Assess impact of audit findings and escalate compliance risks as needed
- Support clinical quality champions in implementing corrective and preventive actions
- Lead investigations into significant quality issues, scientific misconduct, and serious breach of GCP
- Present clinical metrics and escalate systemic and/or critical problems to management
- Work with partner organizations to ensure timelines are met and products are delivered on schedule
- Host and manage inspections of GCP internally and at vendors/partners of studies and/or processes
Skills and Requirements:
- Broad drug experience across all clinical phases (Phase I to IV)
- Demonstrated auditing experience across all types of clinical audits
- Understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations
- Excellent interpersonal, verbal, and written communication skills
- Experience with GXP QA systems, processes, and procedures
- Bachelor's degree in a scientific discipline or equivalent combination of education and experience
- Relevant experience in a GCP audit biotech/pharmaceutical setting
- Ability to build effective relationships (internal and external)
- Excellent verbal and written communication skills
- Ability to understand quality issues in a complex and highly regulated environment
Interested or know someone who might be? Reach out to Josh Godden using the following:
Apply Now:If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, 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. is acting as an Employment Agency in relation to this vacancy.
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Job OverviewID:
1136059
Date Posted:
Posted 2 days ago
Expiration Date:
27/06/2024
Location:
City Of London
Competitive
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