Associate Director/Senior Manager, Clinical QA (remote)

Proclinical is seeking an Associate Director, GCP Quality to contribute to the mission of developing better medicines, faster to work remotely. In this role, you will lead the GCP Quality support for interventional clinical trials, serve as a GCP Quality expert to the business, and establish strong relationships with the Development & Precision Medicine functions.

Key Responsibilities:

• Providing GCP expert advice & guidance to project/study teams.
• Escalation of compliance risks/issues to line management.
• Quality review of GCP essential records.
• Actively contribute to the Quality mission to design & develop a single, fit for purpose QMS.
• Conduct GCP process, vendor, and investigator site audits.
• Support GxP Quality needs in Development & Precision functions, e.g. GVP, GLP, GDP/GMP & CSV.

Requirements:

• Strong GCP Quality experience in biotech/pharma which spans clinical trial phases I to III.
• Expert in GCP global regulations and guidance (e.g. ICH E6, ICH E8, EU CTR, FDA CFRs) and current GCP industry best practices.
• Demonstrates auditing experience across different types of GCP audits.
• Experience of participating in regulatory agency inspections, e.g. MHRA, FDA, EMA) and presenting quality metrics/analytics.
• Bachelor degree in life sciences or healthcare related area.
• Excellent interpersonal and verbal/written communication skills.
• Ability to think outside the box to identify risks/challenges and deliver creative solutions.

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

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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