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Associate Director
4 months ago
- Pay is 100-139/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.
- 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 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
