Director, Clinical Quality Lead

Kardigan•Princeton, NJ

5d•Onsite

About The Position

Kardigan is a heart health company dedicated to preventing, curing, and eliminating cardiovascular disease as the leading cause of death. The company aims to develop targeted treatments for cardiovascular diseases. Led by experienced co-founders who previously led MyoKardia, Kardigan utilizes a cutting-edge discovery and translational research platform with a pipeline of late-stage candidates. The company is driven by patient needs, authenticity, a commitment to learning, teamwork, and enabling the impossible through innovation and risk-taking. These values form the foundation of their work to make a difference. The Clinical Quality Lead will be instrumental in fostering a culture of quality and embedding compliance throughout the R&D process. This role involves managing GxP Quality Assurance (QA) functions and providing expert consultation on GxP regulations (GCP, GLP, GVP), guidelines, policies, and procedures. The position requires collaboration with internal and external cross-functional teams to assess processes, procedures, and activities for adherence to industry standards, regulatory guidelines, and company SOPs.

Requirements

Bachelor’s degree in a scientific discipline
15+ years’ experience in the pharmaceutical or biotechnology industry with in-depth pharmaceutical QMS knowledge
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

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 reports.
Supports Quality Management System (QMS) including quality oversight and operational support for processes such as 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 to 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.