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Associate Director

2 months ago

Foster City, United States ACL Digital Full time

Title: Associate Director

Location: Foster City, CA

Duration: 12 months

Primary 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