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Job Details

Senior Director Quality Assurance (f/m)

Company: SynteractHCR Deutschland GmbH
Location: Anywhere, EU, United Kingdom
Reference: 27417
Closing Date: 20 Mar 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Senior Director Quality Assurance (f/m)   Synteract is an international CRO located in EU, RUS, US and South America. As we are growing we are looking for a dedicated Senior Director for our Quality Assurance department. We offer you a challenging and rewarding job opportunity in a fast moving, flexible environment and a highly motivated team.   Your Tasks Managing the day to day activities of the global Quality Assurance department Overseeing the global QA Team Responsible for...

Requirements:

Senior Director Quality Assurance (f/m)

 

Synteract is an international CRO located in EU, RUS, US and South America. As we are growing we are looking for a dedicated Senior Director for our Quality Assurance department. We offer you a challenging and rewarding job opportunity in a fast moving, flexible environment and a highly motivated team.

 

Your Tasks

  • Managing the day to day activities of the global Quality Assurance department
  • Overseeing the global QA Team
  • Responsible for all activities globally involving quality assurance and compliance of internal operations with applicable regulatory requirements, Good Clinical Practice (ICHGCP), company SOPs and policies, QA validation activities and compliance training
  • Responsibilities include: preparing for, conducting/facilitating and responding to sponsor and regulatory agency audits / preparing for and conducting internal audits / identifying needed actions as a result of internal or external audits, or internal process meetings
  • Participating in establishing, maintaining and updating standards and ensuring compliance of standards with applicable regulatory requirements
  • Reviewing documentation to ensure that controlled documents are followed, standards of quality are maintained, and documentation is complete
  • Ensuring procedural training is complete, documented and in compliance
  • Overseeing quality assurance planning for study related activities
  • Performing review of quality metrics, CAPA findings and business process improvement opportunities, and recommending effective solutions to enhance quality and efficiency, establishing QA processes and standards and compliance related training
  • Developing and approval of software validation documentation and ensuring QA review of executed validation materials and providing consultative advice in related areas (compliance, GCP, QA, standards, clinical research) internally and to sponsors, as needed
  • Management responsibilities include but are not limited to: staffing, project allocation, performance management, employee development, timekeeping and labor law compliance

 

 

Your profile

  • University Degree in Life Science/ related field of study or equivalent
  • Highly experienced in the management of clinical trials on a global large scale
  • 8 + years relevant industry experience inclusive of extensive quality management oversight and experience effectively managing others
  • Expansive knowledge of Quality Management Systems, ICH-GCP knowledge and the conduct of clinical trials
  • Strong organizational and communicational skills
  • Motivated, dedicated and service orientated approach
  • Very good English and Iocal language skills (verbal and written)
  • Advanced IT skills and knowledge of study related systems/ software

 

 

 

 

 

 

To apply

Have we sparked your interest? Then we are looking forward to receiving your application! Please apply through our homepage synteracthcr.com and state your earliest start date/notice period and your desired salary. If you have any questions regarding the position please contact antonia.schultze@synteract.com

 

 

 


Apply for this job: Senior Director Quality Assurance (f/m)

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

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