Country Clinical Quality Manager

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United Kingdom
London
Posting date: 20 Aug 2019
24926_1566296833

A leading global biopharmaceutical company is seeking to recruit a Country Clinical Quality Manager to its office in the UK. The company specialises in bringing forward medicines and vaccines for many of the world's most challenging diseases. This is an exciting opportunity to work with a company that continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world.

Job Responsibilities:

  • Acting as local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes).
  • Manage the local network of owners/Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs)/Work Instructions (WIs).
  • Local expert for any quality-related local processes.
  • Identifying process gaps/opportunities for process improvement and properly escalates to RCQM and/or Global Process Owners (if necessary).
  • Leading continuous improvements activities at the country level and supporting or co-leading continuous improvement activities at the global/regional level.
  • Acting as the local training point of contact and the liaison between local country operations and Learning & Development (L&D).
  • Identifying/coordinating local training needs.
  • Supporting local trainings (as needed).
  • Coordinating and overseeing all QC activities; ensuring a proper execution of the In-house Quality Control Plan (IHQCP), the Quality Control Visits (QCVs), as well as any other QC Checks.
  • Performing QC activities (incl. QCVs) and conducting ad hoc site visits upon request.
  • Identifying local trends, performing root-cause-analysis (if necessary), developing local action plan (incl. sharing of results and training of local country operations, if required).
  • Acting as the primary point of contact for our Research Laboratories Quality Assurance and Regulatory Agencies.
  • Managing and supporting activities during the preparation/ongoing/follow-up phase of an audit or inspection.
  • Performing root-cause-analysis for audit observations/inspection findings, managing and tracking the Corrective and Preventive Actions (CAPAs), and coordinating/facilitating the responses to audit/inspection reports.
  • Identifying local trends, performing root-cause-analysis (if necessary), and developing local action plan (incl. sharing of results and training of local country operations, if required).
  • Communicating/escalating quality/compliance issues (incl. any potential trends) to local country operations management and RCQM.
  • Escalating significant quality/compliance issues per company process and supporting investigations (fact finding, root-cause-analysis) as well as the reporting of 'Serious Breaches', if applicable.
  • Acting as the local POC for escalations of GCP and Privacy Breaches that occurred in clinical trials or supporting local POC for escalations of GCP and Privacy Breaches, if necessary.
  • Evaluating trends on Clinical Supply GCP Inquiries and incorrect management of clinical supplies.
  • Coordinating GCP Investigations of trends related to Clinical Supply GCP Inquiries and incorrect management of clinical supplies (if necessary).
  • Leading local vendor Qualifications and re-qualifications of locally selected GCTO vendors and supporting solving of quality issues with locally selected vendors.
  • Supporting the Quality Management System (QMS) assessment for global and local vendor qualifications and re-qualifications.
  • Communicating compliance concerns to local legal/compliance department and/or our research laboratories Compliance.

Skills and Requirements:

  • Bachelor's Degree or equivalent in relevant health care area.
  • Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.
  • Extensive relevant experience in clinical research, including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.
  • Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.
  • Demonstrated experience leading cross-functional teams of business professionals.
  • Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
  • Solid experience in managing audits and inspections.
  • Solid experience in coordinating and delivering training sessions.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

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 contact Steve Fuller at +44 203 854 263 or upload your CV 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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