United States onlyAbout Us
Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. Led by Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020. We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.
At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries. These values are the foundation of our work, empowering us to make a real difference, every day.
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. The ideal candidate will provide QA leadership for outsourced DHTs used in clinical trials and patient monitoring, ensuring regulatory compliance and patient data protection. Acting as a strategic partner to Quality, IT, Clinical, Regulatory, and Business leadership, this position enables compliant innovation, scalable system and process build‑outs, and sustained inspection readiness aligned with global regulatory expectations.
This role reports to the Senior Director, GxP Quality Systems and may have direct and/or matrixed reports.
This is a 4 day on‑site position - M - Th
Key Responsibilities
Computer System Assurance
- Establish and maintain Kardigan’s enterprise CSA program and operating framework for GxP computerized systems.
- Define and enforce risk‑based assurance approaches aligned with FDA CSA guidance, 21 CFR Part 11, Annex 11, ICH, and global regulatory expectations.
- Provide end‑to‑end quality oversight across the system lifecycle, ensuring systems are fit‑for‑purpose and appropriately designed, implemented, maintained, and retired to support intended use.
- Approve CSA/CSV deliverables as appropriate (e.g., assurance plans, risk assessments, testing strategies, summary reports).
- Ensure appropriate quality oversight of IT‑owned change, deviation, and CAPA processes for computerized systems.
Data Integrity
- Establish and lead an enterprise data integrity program, aligned with ALCOA+ principles and regulatory expectations.
- Define methodologies to assess, monitor, and verify data integrity across GxP computerized systems (activities?).
- Lead proactive, risk‑based identification, mitigation, and remediation of data integrity risks through effective controls and continuous monitoring, driving sustained improvements in data accuracy, traceability, and reliability.
- Partner with Business and IT to ensure systems support accurate, complete, consistent, and secure data throughout the data lifecycle.
- Serve as key partner for enterprise build‑out of data analytic and data governance platforms.
Digital Health Technologies
- Establish and manage a global QA oversight framework for DHTs (largely outsourced) used in clinical trials, real‑world data capture and remote patient monitoring.
- Ensure that products and clinical trial activities and use of DHTs, wearable devices, remote monitoring tools, mobile health (MHealth) apps are compliant with applicable regulations, including adherence to privacy requirements.
Leadership, Engagement & Modernization
- Lead, develop, and inspire a high performing CSA/CSV and data integrity organization, including oversight of external partners, while driving adoption of modern, scalable assurance practices.
- Partner with IT and cross functional leaders to shape system design, technology transformation, and quality modernization, ensuring solutions support automation, interoperability, analytics, and sustainable compliance.
- Serve as a trusted advisor to senior leadership on system risk, compliance posture, inspection readiness, and the effectiveness of CSA and data integrity programs, using metrics and KPIs to inform decisions and continuous improvement.
Qualifications
Required
- 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.
Preferred
- Experience implementing or maturing FDA CSA guidance in a regulated organization.
- PMP, quality, or systems‑related certifications.
- Expertise in ALCOA+, data governance, and data integrity risk management.
- Experience with cloud‑based and validated enterprise platforms.
- Experience supporting regulatory inspections focused on computerized systems and data integrity.
Exact Compensation may vary based on skills, experience and location.
AU, CA + 6 more