Company: SEC Recruitment
Closing Date: 20 Feb 17
Salary (£): Negotiable
Our Client, an international Clinical Research Organisation, with a strong pipeline of projects and ambitious growth plans, is currently looking for a Director Clinical Quality Assurance, to join their organisation in Poland.This is a great opportunity for an experienced QA professional to drive QA strategy of that dynamically growing organisation. ...
Our Client, an international Clinical Research Organisation, with a strong pipeline of projects and ambitious growth plans, is currently looking for a Director Clinical Quality Assurance, to join their organisation in Poland.
This is a great opportunity for an experienced QA professional to drive QA strategy of that dynamically growing organisation.
Description of the role:
To develop and lead a Clinical Quality Assurance function globally to support Clinical Development Operations activities and provide assurance that clinical activities are in compliance with applicable regulations and requirements, ICH GCP guidelines, international standards and policies relating to GCP.
This position oversees all aspects of the GCP Audit Program and ensures successful execution of auditing, deviation management, CAPA management and vendor management.
1) Direct and strategically develop the CQA groups, ensure the best use of capabilities and expertise, and harmonize processes and procedures within CQA.
2) Direct appropriate resourcing budget development and budget management within CQA by strategic assessment of workload, required planning for staffing, coordination of consultant activities as needed and on-going review of forecasted expenditures. Ensure appropriate allocation and utilization of CQA resources.
3) Provide GCP consultancy and other regulatory expertise to support the organization in maintaining required compliance.
4) Lead the development, maintenance, execution and completion of the CQA Audit Program.
Responsible for risk assessments, input of information and tracking progress of the Audit Program.
5) Analyze and report audit observations, gaps and systematic issues to relevant management functions to help to improve processes within Clinical Development Operations as well as affiliates, 3rd party vendors and interfacing functions. Evaluation of adequacy and completeness of corrective and preventative action plans (CAPAs) originated from audits, deviations and/or inspections. Includes communication and presentation of summaries of audit findings, trends, KPIs with recommendations to support continuous improvement.
6) Provide leadership in the preparation, conduct and response preparation relating to health authority inspections and 3rd party audits;
Lead preparation activities for inspections and audits; prepare inspection readiness plans, conduct training; conduct inspection readiness assessments/ mock interviews.
Communicate results and inspection preparedness to appropriate customer groups/ upper management
Act as primary Inspection Coordinator during inspections, including direct interaction with inspectors in preparation, during conduct and follow-up of inspection.
7) Responsible for maintenance and further development of Standard Operating Procedures and training materials related to CQA systems and processes, and ensure coordination with other Quality processes.
University degree in Scientific discipline/Life Sciences or similar.
8+ years’ Pharmaceutical company experience in a Quality Assurance and/or in a Clinical Development related role.
Minimum 3 years’ experience in Quality Management including GCP Auditing, CAPA management, deviation management.
Strong leadership role with experience of GCP regulations and knowledge of regulations and guidelines related to the conduct of clinical trials and research.
Excellent communication skills across all levels of the business.
Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions and actions.
Experience in Quality Systems e.g. Deviation, CAPA and Change management processes
Good customer focus, strong organization, communication, influencing and negotiation skills.
Proficient in English and a local language, and standard MS Office applications.
For more details, please contact Agata Wasko: firstname.lastname@example.org or+442072556665.
3rd Floor, 13-15 Moorgate London.
|Tel:||00 44 (0) 207 255 6600|
|Fax:||00 44 (0) 1483 888997|
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