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Job Details

Head of Quality Assurance GCP

Company: Barrington James Europe
Location:
Reference: QA-HD-GCP
Closing Date: 08 Jul 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

A growing biotechnology company is looking for a Head of Quality Assurance in GCP. You love challenges and want to have a real impact on the work and the foundations of the company, as well as the trajectory for QA. The role will allow you to be a key asset in the development and management of the Quality System of the company.

Requirements:

Responsibilities:

  • Manage the Good Clinical Practice related day to day activities of the Quality Assurance department
  • Be the reference and responsible for all GCP QA activities as SOPS, policies and training, documentation review
  • Preparing, conduction and facilitating audits from internal and external partners as well as supplier sites.
  • Determine and deploy actions and processes regarding the results of the audits.
  • Ensure the compliance of standards and regulations with applicable requirements, maintain and update these standards.
  • Perform review of Corrective and Preventive Actions (CAPAs) and recommending effective solutions to enhance quality and efficiency, establishing GCP QA processes and standards and performing compliance related training
  • Ensure systems at CROs are compliant with regulations and legislations, quality standards as well as company’s expectation.
  • Risk Management for any GCP quality issue, provide directions on measures.

Who are you?

  • You have a university degree, preferably in Pharmacy or related field.
  • Several years of experience in a GCP Quality organization within the pharmaceutical and/or biotechnology industries
  • Ability to function effectively as a member of cross-functional project teams with demonstration of superior leadership skills and ability to work with remote team
  • Extensive knowledge of global Good Clinical Practice, Regulatory Compliance and requirements.
  • You conducted successful inspections and an experience in audits is a plus.
  • Profound knowledge of the commercialization of Advanced Therapy Medicinal Products (ATMPs) in the EU and Regenerative Medicine Advanced Therapies (RMATs) in the US.

Apply for this job: Head of Quality Assurance GCP

Contact Information:

Address:  Head Office
Rowan House Smallfield Road Horley Surrey
RH6 9AU
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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