This position will lead and manage Computer System Validation (CSV) and qualification efforts for systems used across multiple functional business organizations focused on enterprise risk management (REMS-GRM) capabilities and independent legacy systems used in the US and global market supporting regulated processes
Main Responsibilities
- Oversees and executes CSV and QM activities for IT capabilities to ensure ‘fit for use’ before release to production environment.
- Collaborates and works closely with Risk Management Digital Capability Management teams, Customer Care / RM teams, and interdependent Global Product Development & Supply Chain and R&D teams to ensure alignment of principles while identifying opportunities for improvement.
- Supports health authority inspections and internal audits
- Ensures adherence to software development practices, compliance, and key IT controls
- QM representative in problem management and inspection remediation activities
- Performs and provides directions on CSV to understand risk and impact
Requirements:
- BS or equivalent in computer science, engineering, life science or related field
- A minimum of 6-7 years in computer systems validation in the pharmaceutical industry (development of CSV deliverables, execution of software testing, etc., data management, data integrity) including at least 2+ years managing/overseeing CSV projects.
- Candidate must be a subject matter expert (SME) in CSV, GAMP, Electronic Records,/Electronic Signature regulations, and related health authority regulations and guidelines
- Candidate must be technically conversant in concepts and techniques related to software development and data management.
At Bristol Myers Squibb, we’re inspired by this single, powerful vision. Passionate and precise, we bring life-saving medicines to people around the world. And we work together with compassion to improve outcomes for the patients who need us most.
We are a global biopharmaceutical company whose mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases. Innovative science is our passion. Transformational medicines are our goal. Bristol Myers Squibb is committed to discovering, developing, and delivering transformational medicines in areas where we believe we have an opportunity to make a meaningful difference for patients: oncology, immunoscience, cardiovascular, and fibrosis.
We combine the agility of biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
Bristol-Myers Squibb gives you the opportunity to learn and grow professionally alongside smart, creative, and talented colleagues who are committed to helping patients battle serious diseases. Doing amazing things with people you like and admire isn’t something you can find just anywhere.
Our mission to enhance the lives of our patients requires an investment in a strong learning culture. By providing valuable learning opportunities, connecting you to your passion, and helping you achieve your personal aspirations, we are empowering you to make a difference.
This includes:
- Digital Learning
- Developmental Programs
- Leadership & Management Programs
- Insights for Success
- General Manager Development
- Building Manager Capability
- Coaching & Mentoring
