Associate Director

4 weeks ago

Foster City, United States The Fountain Group Full time

About the Company:

Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your scientific insight to partner with internal teams, and external partners as we strive to cure unmet medical needs? We are looking for an expert Quality Assurance Professional with experience advising development teams in IVD and Combination Product quality strategy within a pharmaceutical organization. As a member of the Functional Quality Business Partner Team you will be the medical device subject matter expert within R&D Quality, and key functional development leaders. Specifically, you will partner with Regulatory, Safety, Clinical Operations, and Device Manufacturing to set the quality management system strategy for R&D for medical devices. This role is suited to candidates who possess strong communication, leadership, and strategic risk-based thinking skills. Utilizing expert knowledge in this role you will be a trusted business partner effectively communicating and collaborating with senior stakeholders and leadership teams across the global organization.


About the Role:


  • 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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