Previous Job
Quality Manager
Ref No.: 18-00296
Location: Waltham, Massachusetts
Start Date / End Date: 01/29/2018 to 12/28/2018
Job Title: Quality Manager
Duration: 1 year
Location: Waltham, MA

Job Description:

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

• 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

• Associates or Bachelor's degree preferred
• HS degree + minimum of 3 years of experience required

Shiva Prasad | Senior Recruiter
Sunrise Systems Inc.
Desk: (732) 272 0346
Email: | URL: