Associate Director R&D Quality Assurance Analytics (Remote)
Vertex Pharmaceuticals · USA · posted 1 year ago
As the Associate Director of R&D Quality Assurance (QA) Analytics, you will lead the development and execution of analytics strategies supporting quality assurance activities across clinical and nonclinical R&D. You will oversee data analysis, visualization, and trend monitoring to support proactive compliance, risk mitigation, and operational excellence. This highly cross-functional role will work closely with clinical operations, regulatory affairs, data management, and QA inspection readiness teams.
Key Responsibilities
- Lead the design and implementation of advanced data analytics models to support R&D QA initiatives.
- Develop and manage dashboards and reports to monitor quality trends, key performance indicators (KPIs), and compliance risks.
- Collaborate with cross-functional stakeholders to ensure alignment of analytics with GxP regulations and industry standards.
- Provide actionable insights from internal and external data sources to support audits, inspections, and CAPA management.
- Identify areas of operational inefficiency or non-compliance and recommend continuous improvement opportunities.
- Mentor junior staff and lead training initiatives related to QA data analytics tools and best practices.
- Partner with IT, clinical systems, and data governance teams to ensure data integrity and proper system integration.
Requirements
- Bachelor’s degree in Life Sciences, Statistics, Data Science, or related field (Master’s preferred).
- 8+ years of relevant experience in quality assurance, data analytics, or R&D compliance within the pharmaceutical or biotech industry.
- Deep knowledge of GCP, GLP, and other applicable GxP regulations.
- Proven experience working with analytics tools such as Power BI, Tableau, Spotfire, or similar.
- Strong SQL, Python, or R skills for data extraction and analysis preferred.
- Excellent communication, project management, and cross-functional collaboration skills.
- Experience with audit/inspection support and regulatory interactions is a plus.
Why Join Us
- 100% Remote Work Flexibility
- Competitive Compensation: $150,000–$180,000/year (based on experience)
- Performance Bonus & Equity Options
- Generous Health, Dental, Vision, and Wellness Benefits
- 401(k) with Company Match
- Professional Growth and Development Support
- Inclusive and Collaborative Culture Focused on Innovation and Integrity
Submit your resume and a brief cover letter outlining your relevant experience and interest in the role. Qualified applicants will be contacted for an initial interview.
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