Director, Clinical Quality Lead

Director, Clinical Quality Lead

South San Francisco, California, United States, Princeton, New Jersey, United States

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 authenticleading 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, Clinical Quality Lead

Department: Quality & Compliance

Reports To: Head of CQA

Onsite 4 days - M - Th

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

• 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.

Qualifications and Preferred Skills

• Bachelor's degree in a scientific discipline:
• 15+ years' experience in the pharmaceutical or biotechnology industry with in-depth pharmaceutical QMS knowledge and
• 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), Good Laboratory Practice (GLP, and/or Good Pharmacovigilance Practice (GVP) regulations
• 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

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

Pay range

$194,000 - $253,000 USD