Senior Quality Manager
3 weeks ago
Job Location: Foster City, CA
Job Duration: 12+ months
Payrate: 70-80$/HRRoles and Responsibilities:
Advance the understanding of medical device quality requirements in support of clinical development programs and the regulatory framework to ensure data integrity and patient safety
Support key functions such as Regulatory, Safety, Clinical Operations, and Device Manufacturing on medical device R&D quality strategy
Act as subject matter expert for Quality & Compliance Audit in supporting risk assessments and audit strategy for medical devices
Advise business stakeholders and study teams as needed on quality oversight of outsourced IVD assays for all products; including development of Quality Agreements.
Advise Diagnostic Sub-Teams on matters related to R&D device Quality.
Partner with study teams, including Therapeutic Area quality leads on management of medical device quality issues, vendor oversight and CAPAs
Provide guidance to functions on procedural development and review to assure alignment with internal processes and regulatory requirements for medical devices
Gain insights from metrics and other mechanisms to uncover trends and/or gaps in medical device quality at a portfolio level and advise business on any mitigation requirements
Partner with relevant functional areas to gap assess, investigate and problem solve cross portfolio medical device quality issues; Support functions such as Patient Safety, Clinical Operations and Diagnostics on implementation of Quality Improvement plans.
Provide timely risk-based compliance advice that facilitates decision making
Partner/advise key functional areas in the development & investigation of internal deviations or CAPAs
Participate in quality and/or cross functional process improvements initiatives as assigned
Support key functions and study teams as needed during regulatory inspections.Qualifications:
BA or BS and 10-12+ years of relevant experience (10+ years of relevant experience with an MS)
Significant experience working to or advising R&D business on medical device quality strategy
Understand the use and application of IVD assays in clinical trials
Experience in GCP regulations and guidance, such as ICH E6 R2
Expert in IVD regulations, such as IVDR
GCLP experience is a plus
Understanding of FDA + Global regulations and Guidance for medical devices, and how to apply them in an R&D setting
Must have experience advising business in a compliance related role
Recognized as an expert resource on a range of med device compliance topics
Bio-pharma or Diagnostics Sponsor experience required.
Is a strategic problem solver with a deep understanding of drug development
Exceptional verbal, written, interpersonal skills to include delivering presentations to senior leaders of the organization
Experience with CAPA management programs preferred
Excellent organization and project management skills.
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