Associate Director

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for an

• Advance the understanding of laboratory data in support of clinical development programs and the regulatory framework to ensure data integrity and patient safety
• Support key functions such as Clinical Pharmacology, Biomarker Sciences, Clinical Operations, and Clinical Development on GCLP laboratory quality strategy
• Support laboratory QA strategy for other R&D functions such as Clinical Data Sciences and Research as needed
• Support the Gilead Biologic Sample Management Team in matters related to regulatory compliance including informed consent
• Act as subject matter expert for Quality & Compliance Audit in supporting laboratory risk assessments and audit strategy
• Advise business stakeholders and study teams as needed on quality oversight of outsourced clinical assays for all products
• Partner with study teams, including Therapeutic Area quality leads on management of laboratory quality issues, vendor oversight and CAPAs
• Contribute to the development and maintenance of key lab quality metrics for functions and the quality leadership team
• Provide guidance to functions on procedural development and review to assure alignment with internal processes and regulatory requirements
• Gain insights from metrics and other mechanisms to uncover trends and/or gaps in laboratory 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 laboratory issues
• 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.

• BA or BS and 10-12+ years of relevant experience (10+ years of relevant experience with an MS)
• Significant experience working to or advising business on GCLP quality strategy
• Understand the use and application of bioanalytical and biomarker assays in clinical trials
• Experience in Google Cloud Platform regulations and guidance, such as ICH E6 R2
• Working knowledge of IVD regulations, such as IVDR and IVD quality strategy is a plus
• GLP experience is a plus
• Understanding of FDA + Global regulations and Guidance for GLP/ GCLP, and how to apply them
• Must have experience advising business in a compliance related role
• Recognized as an expert resource on a range of lab compliance topics
• Bio-pharma sponsor experience preferred
• 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