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Sr Manager, Supplier and QMS QA

King of Prussia, PA 19046

Posted: 01/27/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 535117 Is job remote?: No Country: United States

Job Description


The Sr Manager QA will:
  • Support integration activities resulting from Gyroscope QMS assessments in accordance with Novartis transition plans as well as ensure data integrity practices are followed as per applicable procedures.
  • Support vendor qualifications according to procedures and approved plans such as managing progress on quality assurance agreements with vendors, closure of audit responses and follow up on CAPA activities.
  • Report applicable quality metrics and KPIs.
  • Support change management activities within the organisation, including facilitating and documenting changes impact assessment and other related activities as per applicable procedures.
  • Any other projects or assignments, as cascaded or delegated by supervisor.

Skills And Requirements
  • Bachelors degree in the science or a related field
  • Minimum 7 years of experience in a GxP regulated industry
  • Previous experience in variety of Quality Assurance roles including QMS supporting and Supplier QA.
  • Previous experience in organizations supporting clinical trials.
  • Experience in gene therapy or use of MasterControl is a plus.
  • Strong organizational skills and attention to detail
  • Strong interpersonal and communication skills
  • Excellent technical writing and problem-solving skills.
  • Ability to work effectively at a fast-paced environment with cross functional departments.
  • MS Office proficiency
  • Past experience managing complex projects is required.

Pay Rate Ranges between $25-50/hr
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