13 days old
2018-01-092018-02-06

Quality Manager- R&D programs

Waltham, MA 02451
  • Job Code
    595084
  • Payrate
    $50 To $60

Quality Manager


Independently support operational and technical aspects of all R&D programs. Ensure compliance and support of company Standards, Practices, and SOPs as well as ICH and FDA guidelines.


Design stability protocols, expiry dating for clinical expiry dating for clinical/commercial products, providing stability sections for regulatory submissions, technical assessment of stability data, specification changes and investigations and ensure timelines are met for release and stability testing of product.


- Lead Quality Process and Quality Improvement Initiatives across R&D


- Perform quality review of existing business processes, SOPs and assist team with developing lean processes where needed


- Develop metrics, analytics and dashboards for Key Quality Indicators for clinical teams, R&D functions and R&D vendors/partners


- Support RD Quality team with audit management and inspections, particularly around metrics, CAPA management and documentation processing


- Act as Project Manager for key initiatives managing timelines, budgets (if applicable), and deliverables from a cross-functional team


Requirements:


- Process development and Program Management experience


- 2-3 years' experience of Clinical Research industry experience


- Strong Microsoft Suite; Word, Excel, PowerPoint etc


- Database management and analytic skills required


Education:


- Associates or Bachelor's degree preferred


- HS degree + minimum of 3 years of experience required

Categories

  • Information Technology

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Quality Manager- R&D programs

Randstad Technologies
Waltham, MA 02451

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Randstad Technologies
Waltham, MA
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