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Job Details

Manager, Quality Assurance (QA) Compliance

Company: Chiltern
Location: Slough to start with - moving to Maidenhead in Autumn 2018
Reference: MLJMQAC
Closing Date: 18 Sep 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Chiltern (a Covance company) are currently recruiting for a full time Manager, Quality Assurance (QA) Compliance. Ideally you will have either facilitated or conducted GCP audits within either pharma or CRO. Or perhaps you have held a QA/compliance role and have been through the inspection process and have been actively involved in preparation and follow up.

Requirements:

Job Background

Chiltern (a Covance company) are currently recruiting for a full time Manager, Quality Assurance (QA) Compliance. Ideally you will have either facilitated or conducted GCP audits within either pharma or CRO. Or perhaps you have held a QA/compliance role and have been through the inspection process and have been actively involved in preparation and follow up. We may consider a Senior Associate level who wants to grow into a more managerial position. This is an office based role ideally but we may consider local home based as long as you can travel frequently to Slough and Maidenhead. OVERVIEW This position provides management support to the QA & Compliance Department, with duties primarily focused on quality system, compliance and audit related tasks and responsibilities. These may include (but will not be limited to) management of tasks related to Sponsor audits and regulatory inspections; Document Control; GCP Escalation Committee (GEC); Corrective / Preventive Actions (CAPA); Quality data analysis, trending and reporting; Quality Improvement initiatives; Development and maintenance of the Chiltern Quality Management System (eQMS); Customer feedback; Quality oversight (inclusive of governance, quality agreements / plans and metrics) and risk management. The Manager, QA Compliance role may have responsibility for line management of QA Administrative Assistances; QA Audit Associates; QA Compliance Associates; QA Auditors; Manager, QA Compliance; and Manager, QA Auditing positions.   1. Responsible for management, hosting and follow-up of client audits and regulatory inspection activities. 2. Responsible for management of Document Control activities. 3. Responsible for management and coordination of GEC Meetings and follow-up of any resulting actions. 4. Responsible for management of Corrective / Preventive Actions (CAPAs). 5. Responsible for management of quality data analysis, trending and reporting. 6. Responsible for coordination and management of quality improvement initiatives and projects, as assigned. 7. Responsible for management of the development, implementation, maintenance and support of Chiltern’s electronic Quality Management System (eQMS). 8. Responsible for management of the Customer Feedback process. 9. Responsible for management of Quality Agreement and/or Quality Plans as part of established Sponsor governance and quality oversight. 10. Responsible for management of collation and reporting of quality metrics. 11. Responsible for management of risk management strategies. 12. Responsible for management of QA departmental training compliance and employee induction training requirements, as needed. 13. Responsible for the hiring, performance appraisal, performance management, training, and career development of a team of QA staff. 14. Responsible for management of the resource aspects of their assigned team, contribute to operational reports, through contribution to the staff allocation process as required. 15. Actively seek feedback, and monitor the quality of their team member’s work on an ongoing basis, through review of appropriate documentation and accompanied visits, as deemed appropriate to the team member’s position. 16. Serve as a role model, mentor and/or supervisor (when needed) for less experienced QA staff. 17. Escalate issues (as needed) to Senior QA Management. 18. Ensure that systems and processes agreed by management and implemented will ensure that Clinical Trials have been performed and data is generated in compliance with ICH-GCP and other regulations. 19. Actively participate in training sessions and workshops, including presenting reports from any conferences attended. 20. Ensure timely completion and documentation of all training requirements. 21. Remain abreast of, and apply, updates to regulations, guidelines and principles related to Good Clinical Practice (GCP) and advise on their use and compliance. 22. Deputise for the Line Manager, as required. 23. Perform any other duties, as required by the Quality Assurance department. REQUIREMENTS High School Diploma (or equivalent) required University Degree in a biomedical or related life science, nursing or engineering qualification beneficial Minimum of 3-5 years’ experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job Key words Quality Assurance, GCP, Compliance, Auditing, CAPAs,  regulatory, inspections, quality management, QA Please call Marc Joseph on 44 (0)1753 216664 for further information or send your application to marc.joseph@chiltern.com
  Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Salary

On Application

Position Type

Permanent
Full Time

Contact

Email Marc Joseph - Marc.Joseph@chiltern.com
+44 (0) 1753 216 664

Apply for this job: Manager, Quality Assurance (QA) Compliance

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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