Director, Clinical Quality Lead

Kardigan; South San Francisco, Princeton (CA, NJ); On-site; USD 194,000 - 253,000; Full time

Job summary

Kardigan is seeking a Clinical Quality Lead to drive a culture of quality across R&D, ensuring GxP compliance and consultation on GCP/GLP/GVP guidelines. You will collaborate with cross‑functional teams to evaluate processes, SOPs, and regulatory readiness, and oversee QA functions including CAPAs and audits.

Required are strong leadership, extensive QA/GxP experience, and the ability to travel and work on site.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 7+ years in a QMS environment with discovery and development.
• Direct experience with internal/external clinical systems and process audits.
• Experience in QA audits of Clinical Investigator sites and clinical vendors.
• Experience in SOP development and GCP knowledge.
• Strong communication and leadership skills.

Responsibilities

• Partners with Clinical Development and participates in study teams for GCP compliance.
• Maintain internal audit program, schedule, and vendor list.
• Perform internal and external audits to ensure GXP compliance.
• Communicate audit results and write audit reports.
• Support QMS activities including CAPAs, inspections, deviations, risk, and change control.
• Monitor and trend GxP non-conformances and CAPAs.
• Lead or support regulatory inspections and CAPA development.
• Maintain regulatory inspection knowledge across worldwide agencies.
• Interpret global regulations to update policies and standards.
• Build cross-functional GxP compliance awareness in R&D.
• Assist training initiatives on processes and new regulations.

Skills

GxP compliance

Quality audits

CAPA

Root cause analysis

Risk management

GCP

Leadership

Communication

MS Office

SharePoint

Education

Bachelor's degree in science

Tools

SharePoint

MS Office

Job description

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 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.

Job Overview

The Clinical Quality Lead will play a crucial role in driving a culture of quality and ensuring that compliance is embedded throughout the R&D process. This role will be responsible for managing GxP Quality Assurance (QA) functions and providing consultation in the interpretation of GxP regulations (GCP, GLP, GVP), guidelines, policies, and procedures. This involves engaging and collaborating with cross‑functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate.

Essential Duties and Responsibilities

Essential duties may include the following tasks depending on level of experience

• Partners with Clinical Development/Operations and actively participates in clinical study teams to ensure GCP compliance. Reviews study‑related documents and plans.
• Support and maintain the internal audit program, audit schedule, and approved vendor list.
• Performs internal and external audits as assigned to ensure compliance with GXP regulations and guidelines.
• Communicates audit results to internal stakeholders and writes audit report.
• Supports Quality Management System (QMS) including quality oversight and operational support for processes as e.g. CAPAs, audits, inspections, deviation management, risk management, change control and quality complaint handling.
• Monitor, track, and trend GxP non‑conformances, deviations, CAPAs
• Leads or supports audit and inspection activities, including CAPA formulation, vendor assessments, and regulatory inspections.
• Responsible for maintaining current regulatory inspection knowledge as it relates inspections by regulatory agencies worldwide
• Interprets global legislation, regulations and guidance for development or updates to policies and standards, identify gaps and redundancies
• Leads or supports backroom activities during regulatory authority inspections and assists with GxP inspection readiness activities.
• Build and maintain cross‑functional relationships to promote GxP compliance awareness throughout the R&D organization (GCP, GVP, GLP).
• Support in training initiatives on processes, new regulations and systems to enable quality compliance.
• Contribute to defining and monitoring compliance and quality metrics to ensure oversight of processes and projects and management review.

Basic Qualifications

• Bachelor’s degree in a scientific discipline
• 7+ years in a QMS environment with proven experience in discovery, as well as non‑clinical and clinical development
• Direct experience with internal/external clinical systems and process audits
• Experience in QA audits of Clinical Investigator sites and clinical vendors
• Experience in the development of SOPs
• Knowledge and experience in Good Clinical Practices (GCP)
• Strong interpersonal, negotiation, and leadership skills.
• Excellent written and verbal communication skills, with experience working in a culturally diverse, global team
• Ability to work independently and effectively prioritize tasks
• Expertise in Root Cause Analysis, CAPA development, and Risk Management methodology
• Insightful, decisive, proactive, and solutions‑oriented
• Proven excellence in professional skills including communication, organization, prioritization, discretion, and accuracy
• Exceptional customer service skills, including cultivating and maintaining close working relationships with both internal and external stakeholders
• Proficiency in MS Office including Word, Excel, PowerPoint, Outlook, SharePoint, OneNote, and virtual meeting
• Available to travel as needed
• Available to be on site 4 days/week

Preferred Qualifications

• 15+ years’ experience in the pharmaceutical or biotechnology industry with in‑depth pharmaceutical QMS knowledge
• Knowledge and experience in Good Laboratory Practice (GLP, and/or Good Pharmacovigilance Practice (GVP) regulations

Exact Compensation may vary based on skills, experience and location.

Pay range

$194,000 - $253,000 USD

As set forth in Kardigan’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service‑connected disability.

A "recently separated veteran" means any veteran during the three‑year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

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