Overview
Director, Clinical Quality Lead Jobs in South San Francisco, USA at Kardigan
Position Title:
Director, Clinical Quality Lead
Department: Quality & Compliance
Reports To: Head of CQA
Work Location: Onsite 4 days – Sunday to Thursday
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. The Lead will engage and collaborate 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).
Essential Duties and Responsibilities
- Partner with Clinical Development/Operations and actively participate in clinical study teams to ensure GCP compliance; review study‑related documents and plans.
- Support and maintain the internal audit program, audit schedule, and approved vendor list.
- Perform internal and external audits to ensure compliance with GxP regulations and guidelines.
- Communicate audit results to internal stakeholders and produce audit reports.
- Support the 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, and CAPAs.
- Lead or support audit and inspection activities, including CAPA formulation, vendor assessments, and regulatory inspections.
- Maintain current regulatory inspection knowledge related to inspections by regulatory agencies worldwide.
- Interpret global legislation, regulations, and guidance to develop or update policies and standards, identifying gaps and redundancies.
- Lead or support backroom activities during regulatory authority inspections and assist with GxP inspection readiness activities.
- Build and maintain cross‑functional relationships to promote GxP compliance awareness throughout the R&D organization.
- Support 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.
- 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 developing SOPs.
- Knowledge and experience in Good Clinical Practices (GCP), Good Laboratory Practice (GLP), and 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 communication, organization, prioritization, discretion, and accuracy.
- Exceptional customer service skills, including cultivating and maintaining close working relationships with internal and external stakeholders.
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook, SharePoint, One Note) and virtual meeting platforms.
- Availability to travel as needed.
- Availability to be on site 4 days per week.
Compensation
Pay range: $194,000 – $253,000 USD (may vary based on skills, experience, and location).
EEO Statement
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.
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Title: Director, Clinical Quality Lead
Company: Kardigan
Location: South San Francisco, USA
Category:
