An excellent opportunity has arisen to join a leading pharmaceutical company as a Quality Assurance Manager focusing on GCP.
This newly created position within Quality Assurance is responsible for monitoring and evaluating the compliance and oversight of clinical studies (multiple phases II and III), corporate policies and SOPs with FDA and international regulations and guidelines as well as for the establishment of the GCP quality system. The position will work in collaboration with the Global Director of Clinical Operations to provide QA oversight of investigative sites, partner vendors (CROs), and internal departments to develop and implement programs for appropriate regulatory compliance.
*Plan, conduct and report on GCP audits of clinical investigators, vendors (CROs) and systems plus key reports and documents
*Support the internal audit process with regards to documents and compliance
*Provide support during regulatory inspections and internal audits
*Review study documents and check for consistency and appropriate standards and practices
*Prepare, update and maintain GCP quality system, based on SOPs in compliance with relevant regulatory guidelines
*Act as the GCP QA functional area representative for all sponsored clinical studies
*Ensure compliance with the Clinical Operations team within the quality management system, including training and processing Quality Events and CAPAs as needed
*When appropriate, prepare and/or revise relevant SOPs and Work Instructions
*Continuously improve processes and systems in accordance with company standards and global regulatory requirements
*Develop and present GCP training programs to internal and external stakeholder
*Degree in life sciences (Bachelor, Master or PhD in Biology, Pharmacy, Chemistry)
*Minimum 2 years working experience in a Clinical Quality environment in Pharma, Biotech or Medical Device industry
*CRA experience is an advantage
*Strong team player with integrity, commitment to quality and ability to think critically and creatively as well as work independently
*Strong verbal, written, presentation and communication skills
*Fluency in English (verbal and written), an additional European language is preferred
Key People is a specialist international recruitment consultancy with over 25 years' experience of working within the life sciences, biotech, healthcare and CRO industries. Our experienced and dedicated clinical research related consultants have a long history of success, excellent technical knowledge and a flexible, consultative focussed approach to recruitment.
Please contact Mark Cussens, Clinical Research Recruiter on
Tel: +44 1727 817623 or email: email@example.com
Tel: +41 4350 86620 or email: firstname.lastname@example.org
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