Director, Clinical Quality Lead

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

1. 1Partners with Clinical Development/Operations and actively participates in clinical study teams to ensure GCP compliance. Reviews study-related documents and plans.

1. 2Support and maintain the internal audit program, audit schedule, and approved vendor list.

1. 3Performs internal and external audits as assigned to ensure compliance with GXP regulations and guidelines.

1. 4Communicates audit results to internal stakeholders and writes audit report.

1. 5Supports 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.

1. 6Monitor, track, and trend GxP non-conformances, deviations, CAPAs

1. 7Leads or supports audit and inspection activities, including CAPA formulation, vendor assessments, and regulatory inspections.

1. 8Responsible for maintaining current regulatory inspection knowledge as it relates inspections by regulatory agencies worldwide

1. 9Interprets global legislation, regulations and guidance for development or updates to policies and standards, identify gaps and redundancies

1. 10Leads or supports backroom activities during regulatory authority inspections and assists with GxP inspection readiness activities.

1. 11Build and maintain cross-functional relationships to promote GxP compliance awareness throughout the R&D organization (GCP, GVP, GLP).

1. 12Support in training initiatives on processes, new regulations and systems to enable quality compliance.

1. 13Contribute to defining and monitoring compliance and quality metrics to ensure oversight of processes and projects and management review.