Quality Computer System Assurance (CSA),  Data Integrity (DI) & Digital Health Technologies (DHT).

Kardigan is seeking a hands-on, strategic Head of Quality Assurance for CSA, DI & DHT. This role will establish and maintain a modern CSA framework across GxP environments, while advancing data integrity maturity across the enterprise.

Requirements

• Bachelor's degree in Computer Science, Information Systems, Life Sciences, or related discipline; Master's degree preferred.
• 10+ years of experience in CSA, CSV, data integrity, quality systems, or regulated IT within pharmaceutical, biotech, or medical device environments.
• Proven experience leading enterprise CSA/CSV frameworks for GxP computerized systems at scale, grounded in risk-based assurance and end-to-end system lifecycle expertise.
• Experience in implementing or overseeing digital health solutions and wearable technologies in clinical and/or commercial biopharma settings.
• Strong working knowledge of FDA, EMA, ICH, 21 CFR Part 11, Annex 11, GAMP5 and emerging global on DHTs.
• Proven leadership experience managing teams, vendors, and cross-functional initiatives.
• Experience in startup or growth-stage companies preferred; must be comfortable in a fast-paced, evolving environment.
• Excellent communication, influence, and change management skills.

Benefits

• 401k Matching
• Retirement Plan
• Generous Paid Time Off
• Tuition Reimbursement
• Relocation Assistance