Software Validation Team Lead

Celerion; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

Celerion is seeking a Software Validation Team Lead to manage a dynamic team and ensure IT systems comply with stringent regulatory standards. With the autonomy to shape validation strategies, this fully remote role offers both challenge and leadership opportunity, contributing to impactful clinical research initiatives.

Qualifications

• 5+ years in software validation within GxP environments.
• 3+ years of line manager experience.
• Strong knowledge of 21 CFR Part 11, GMP/GLP/GCP requirements.

Responsibilities

• Lead a team of 6 validation analysts and drive strategic validation initiatives.
• Develop validation approaches for critical GxP systems.
• Oversee end-to-end validation projects.

Skills

Communication

Problem-Solving

Organizational Abilities

Education

Bachelor's degree in computer science or health sciences

Job description

Celerion is committed to swift, exceptional clinical research through translational medicine.Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Ready to lead the future of GxP systems validation?

Join Celerion’s dynamic team as a Software Validation Team Lead and play a pivotal role in ensuring our IT systems meet the highest regulatory standards. You'll lead a talented team of validation analysts, testers, and business analysts while driving strategic validation initiatives across our organization.

This role can be fully remote, ideally working in the Central or Eastern time zone, or willing to work normal business hours in Central time.

What You'll Do

• Lead & Inspire: Manage a dedicated software validation team of 6 and guide them to success
• Drive Strategy: Develop validation approaches for critical GxP systems and ensure compliance with GAMP principles and 21 CFR Part 11
• Deliver Results: Oversee end-to-end validation projects, from planning through execution and reporting
• Collaborate: Work closely with IT, QA, and cross-functional teams to deliver compliant systems
• Represent Excellence: Support regulatory inspections and sponsor audits with confidence

What You Bring

• Education: Bachelor's degree in computer science, health sciences, or equivalent experience in pharmaceutical/clinical settings
• Experience: 5+ years in software validation within GxP environments, plus 3+ years of line manager experience
• Expertise: Strong knowledge of 21 CFR Part 11, GMP/GLP/GCP requirements, and validation best practices
• Skills: Exceptional communication, problem-solving, and organizational abilities

Why You'll Love It Here

This role offers the perfect blend of technical challenge and leadership opportunity. You'll have the autonomy to shape validation strategies while working with cutting-edge IT systems that make a real difference in clinical research.

Ready to validate your next career move? We'd love to hear from you!

#LI-Remote

Celerion Values: Integrity Trust Teamwork Respect

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.