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Job Details

CSV Director - Large Biotech

Company: TEC Group International
Location:
Reference: MGGOLBCSVD
Closing Date: 28 Feb 19
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

You will be the lead of all Validation/Compliance operations, activities and you must develop, implement and maintain the relevant standards throughout. You will be the oversight of IT, GxP decisions and the subsequent validation strategy. You must have 10+ years’ experience in Quality Assurance/Validation, 5+ years in management within Quality Assurance/Validation and have a bachelor’s degree in computer science, engineering or related field.

Requirements:

Head of Validation / Director of Compliance / Compliance and Validation Lead / Site Quality Director / QA Validation Manger / Head of CSV Compliance

I am currently working with one of the world’s leading biotech company that focuses on areas that have high unmet medical needs. They use their expertise to tackle solutions that improve health outcomes and extensively improve the lives of people. They have an in-depth set of values they strive to uphold including the assurance of quality, value for patients and teamwork in a science-based team environment.

Qualifications/Experience

  • 10+ years’ experience in Quality Assurance/Validation
  • 5+ years management in Quality Assurance/Validation
  • Bachelor's degree in Computer Science, Engineering or related field
  • Ability to deal with ambiguity and flexibility to work collaboratively with others in a dynamic environment
  • Ability to prioritize duties and manage multiple matters from start to finish with minimal supervision
  • Exceptional attention to detail and excellent organizational skills
  • Preferable experience in R&D with assay and method development and Quality/Information Technology/Engineering and Lab experience
  • Strong knowledge of GMP, GLP, GCP, Medical Devices and EU regulations

Responsibilities (include but not limited to)

  • Enterprisewide responsibility for IT Quality System Compliance Controls, CSV standardization inclusive of platform qualifications, and vendor management
  • Oversight of IT GxP decisions and the subsequent validation strategy
  • Strategy, direction and execution of Quality & Validation activities
  • Accountable to operate and grow the Quality & Validation Department 
  • Part of the leadership team which collaborates with a variety of clients and stakeholders across the organisation
  • Provide strong leadership, strategic planning, quality and validation oversight

My name is Megan, I am a consultant specialising within Quality Assurance, to find out about this opportunity, similar opportunities or get expert advice regarding your next step contact me via:

Phone: +44 2085443429

Email: mgoodwin@tgilifesciences.com

LinkedIn: linkedin.com/in/megan-g-821459103

 

Apply for this job: CSV Director - Large Biotech

Contact Information:

Address:  Head Office
Dowgate Hill House, 14-16 Dowgate Hill, London
EC4R 2SU
England
Tel:  +44 (0) 208 544 3400
Website:  Visit Our Web Site

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