GCP QA, Senior Manager

Proclinical is currently recruiting for a GCP QA Senior Manager for a biopharmaceutical company located in Wilmington, DE. Successful candidate will provide global audit support and GCP oversight of Clinical Operations teams to the Head of QA-GCP.

Job Responsibilities:

• Plan, schedule and conduct audits of Clinical Investigator Sites, CROs, and Clinical submission documents.
• Coordinate responses and corrective actions from audit findings.
• Provide GCP advice and support to Incyte Clinical Operations and other relevant functions.
• Stay abreast of clinical trial requirements, FDA, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the US/EU and other regions, as appropriate.
• Assist in the review and revision of Clinical Development and QA SOPs.
• Conduct GCP training for Incyte staff.
• Alert QA GCP Management of internal and external GCP compliance and clinical trial issues in a timely manner.
• Assist with the development, maintenance, and reporting of metrics defined by QA.
• Support Quality management initiatives and Quality improvement plans for QA and defined business
• Become thoroughly familiar with assigned compounds and protocols.
• Provide support for regulatory authority inspections including conducting pre-inspection audits of sites.
• Assist with the management of QA consultants performing audits.

Skills and Requirements:

• Bachelor's degree.
• 5 years' experience in a pharmaceutical or biopharmaceutical company in a GCP QA role with 5+ years' experience performing GCP audits of CROs and investigator sites.
• Strong written and oral communication skills.
• Prior Regulatory inspection experience desired.
• Ability to travel up to 30%.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 646-878-6308 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

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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