Senior Life Sciences Consultant
2 days ago
We thrive in a culture built on transparency, diversity, integrity, and learning. If you enjoy an environment that encourages innovation and excellence, professionally and personally, you'll find your career rewarding.
Key Responsibilities:
- Deliver validation projects across various domains, including R&D, Clinical, Quality, Regulatory, Digital Transformation, Platform Implementation, and Automation within the GxP environment.
- Provide expertise to clients as a Life Sciences Subject Matter Expert, staying up-to-date on industry developments and sharing insights through publications and customer meetings.
- Offer compliance guidance to stakeholders on computerized system validation (CSV) in a GxP regulated environment.
- Oversee validation and qualification processes for GxP computerized systems and infrastructure to ensure 21 CFR Part 11 compliance.
- Evaluate new systems for GxP impact and provide risk-based validation guidance.
Requirements:
- 4-8 years of experience in management consulting or relevant roles within the life sciences industry.
- Proven experience in IT compliance and validation within a GxP regulated environment, specifically with 21 CFR Part 11 compliance.
- Strong understanding of regulatory requirements and industry standards in life sciences.
- Experience advising customers in areas such as patient journey mapping, cross-platform integration and innovation, clinical data management, and digital analytics.
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