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