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Quality Assurance Director - Biotech

  • Job type: Permanent
  • Location: Fargo
  • Salary: $100000 - $135000 per annum
  • Job reference: MERZ0312182018453
  • Sector: EPM Scientific, Quality
  • Date posted: 12/03/2018
  • Rapidly Growing Biotech Company
  • North Dakota
  • $100,000 - $135,000 + Bonus + Excellent Growth Opportunity
A rapidly growing Biotech company is urgently looking for a QUALITY ASSURANCE DIRECTOR to lead the team! This company is one of the leaders within the specializations for protein production, plasmid DNA, and antibody generation. They have completed over 50,000 projects in plasmid manufacturing, produced proteins for the usage regarding a wide range of biomedical and agriculture applications, and has antibodies that were validated in more than 130 publications and patents for over 500 clients!

The QUALITY ASSURANCE DIRECTOR will be responsible for maintaining and establishing the continuous improvement with respect to cGMP Quality Operation functions (Change Control, Quality Sytems, Document Control, Vendor/Supplier QA, Training) ensuring compliance to all phase appropriate requirements in relation to GMP, ICH and EMA regulations. The QA DIRECTOR will manage QA duties in support of manufacturing, testing & release of finished product under FDA/EU regulations. Other activities will involve conducting investigations for GMP related issues, overlook change control process, SOP, GMP training programs, amongst other responsibilities.

The Quality Assurance Director will be responsible for the following duties:
  • Overlook the internal and external audit program, including the focus on cGMP compliance, regulatory agency & client inspection readiness
  • Require monitoring and approval of suppliers of materials
  • Direct, manage, and plan the duties of Quality groups, and provide technical leadership to deviation, change controls, and CAPA
  • Lead and implement cross-functional corporate quality audit program in order to monitor compliance with internal and regulatory standards and internal procedures
  • Ensure training and cross-training of the QA team

The Quality Assurance Director will have the following qualifications:

  • Bachelor's Degree within the Life Sciences space
  • 10+ Years experience within a Quality role
  • 3+ Years experience in a leadership position (team leader, manager, supervisor)
  • Expertise in GMP; strong working knowledge of FDA & EU regulations in relation to the manufacturing of biologics
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