This listing was posted on Professional Diversity Network.
Clinical Quality Assurance
Location:
Foster, QC
Description:
Associate Director, Clinical Quality Business Partners, Laboratory Compliance, R&D Quality & Medical Governance (Foster City, CA) We are looking for an expert Quality Assurance Professional with experience advising research and development teams in Good Clinical Laboratory Practices (GCLP) quality strategy within a pharmaceutical organization. As a member of the Clinical Quality Operations Excellence team, you will provide leadership provide GCLP subject matter expertise within R&D Quality & Medical Governance, and key functional research and development leaders. This role is suited to candidates who possess strong communication, leadership, and strategic risk-based thinking skills. Utilizing expert GCLP 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. Primary Responsibilities: 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 Client 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 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 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 About Client R&D Quality and Medical Governance Client R&D Quality and Medical Governance is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do. We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career. Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world As an equal opportunity employer, ICONMA prides itself on creating an employment environment that supports and encourages the abilities of all persons regardless of race, color, gender, age, sexual orientation, citizenship, or disability
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to Professional Diversity Network
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.
More About this Listing: Clinical Quality Assurance
Clinical Quality Assurance is a Quality Assurance QA Job at Iconma located in Foster QC. Find other listings like Clinical Quality Assurance by searching Oodle for Quality Assurance QA Jobs.
Clinical Quality Assurance is a Quality Assurance QA Job at Iconma located in Foster QC. Find other listings like Clinical Quality Assurance by searching Oodle for Quality Assurance QA Jobs.