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Job Details
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Clinical QA Manager - Cutting Edge Oncology Products



Business Type: Pharmaceutical Company
Job Type: Clinical Research, Quality Assurance - Control
Job Level: Management
Position: Full Time
Salary: GBP70000 - GBP90000 per annum + 15% Bonus and £6000 Car Allowance
Location: Hertfordshire
Reference: EL. 206323.30
Closing Date: 14/08/19
Job Details:

The senior Clinical QA Manager will be responsible for ensuring compliance of Pharma Clinical activities with global regulatory requirements and regulations.

Working with rare disease and oncology products, this is great chance to be involved with a really exciting portfolio.

The manager will have oversight on the Quality Management System related to his area of responsibility, including but not limited to review of contracts and clinical documents, preparation, performance and follow up of internal and external audits, preparation and hosting of inspections, review and approbation of Clinical related deviations and potential complaints, develop corrective and preventative actions (CAPAs) associated with findings and quality events, and will support compliance requirements for incorporation into company systems/procedures.

The Clinical QA Manager will also be the leader of continuous improvement projects, agency regulations, GxP, Industry Guidelines, local regulations, along with policies and procedures for the conduct of clinical trials.

This involves working closely with Clinical Operations, Supply Chain, Regulatory, and other supporting areas/development teams, to help ensure active participation in continuous quality improvement activities.

Requirements

  • A minimum of a Bachelor of Science degree.
  • A minimum of 8 years of relevant experience in GCP/clinical quality assurance with a minimum of 2 years of Good Clinical Practices (GCP) auditing
  • In‐depth knowledge and clear understanding of GCP regulations and industry standards, covering EU and FDA regulations, ICH guidelines, other relevant global requirements in the post market and clinical trial environment required.
  • Knowledge of other Health Authority requirements highly desired.
  • Must be able to interpret and apply regulations and guidances
  • Maintains professional expertise and knowledge of local and international regulations related to Quality.
  • Strong organizational skills/attention to details, and ability to adapt in a fast paced constantly changing environment required.
  • Clear, effective written and verbal communication skills required.
  • Ability to work under pressure in order to meet tight deadlines is required as is good interpersonal skills (i.e., team player).
  • The successful candidate is required to have strong analytical/judgment capabilities to understand/analyse/synergise and communicate.
  • A broad knowledge of Pharmaceutical regulatory compliance best practices is preferred. Project management skills including management of both time and priority constraints.
  • Good knowledge of medical terminology highly desirable.
  • Flexibility to work with colleagues in a global setting

Able to engage in work-related travel when required (potential travel to the US and Europe (approximately 1/month).

For a confidential discussion about this, please contact Edward Little on 0207 940 2749 (EXT: 7168) or send your updated CV in a word document to E.Little@nonstop-recruitment.com

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.



Posted: 07/08/2019 | NPJ Ref: 239806
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