Associate Director - San Mateo, United States - The Fountain Group

The Fountain Group San Mateo, United States

3 weeks ago

Description

Job Description:

Pay is /hr based on experience to start.
Hours start off at 32 hours/ week, Mon-Thurs, or Tues-Fri, after 2 months, position will become 40 hrs/ week, Mon- Friday, regular business hours.
Position is initially an 8-month contract, highly likely to extend or convert permanent.
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 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.

Qualifications:

BA or BS and 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 GCP 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

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