Director, Product Quality Lead

About 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 Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading Myo Kardia 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.

Position Title:

Director, Product Quality Lead
Department:
Quality

Reports To:

VP, CMC Quality

Location:

Princeton, NJ (Preferred) or South San Francisco, CA - On site 4 days a week (Mon to Thurs)

Kardigan is seeking a Director, Product Quality Lead (PQL) to provide end-to-end Quality leadership for designated products as the company advances toward becoming a global, multi-product commercial-stage biopharmaceutical company. The PQL is accountable for ensuring that the right product quality strategy, risk posture, and execution plan are in place in a compliant, phase-appropriate manner. This role spans the product lifecycle from pre-clinical and first-in-human development through pivotal clinical trials, commercial filing and approval.

Scope includes critical raw materials (where applicable), intermediates, drug substance, drug product, process validation, technology transfer, and external manufacturing quality oversight. The successful PQL combines deep CMC development experience, strong Quality judgment, and practical business orientation. They guide CMC program teams by articulating the impact of trade-offs and residual risks, and making timely risk-based decisions that balance science, compliance, quality, innovation, and patient need.

CMC Program Leadership:
Develop and drive the end-to-end product quality strategy for assigned products, ensuring alignment with program objectives, regulatory expectations, and long-term commercialization goals. Serve as the Quality representative on CMC program teams, ensuring quality expectations and deliverables are clearly defined and achieved across technical functions. Provide Quality oversight of development and manufacturing activities, ensuring phase-appropriate application of GMP and regulatory requirements.

Partner cross-functionally to ensure product quality considerations are effectively integrated throughout the product lifecycle. Orchestrate the development of an end-to-end control strategy, partnering…