Director Strategic Advice - R&D Quality Assurance

Role Summary

Director Strategic Advice – R&D Quality Assurance, focused on influencing strategic directions on quality and compliance as the GVP/GCP expert for clinical and post-market activities within a science-driven environment.

Responsibilities

• Work closely with R&D stakeholders to provide leadership in influencing strategic direction on quality and compliance through GCP/GVP expert advice related to clinical and post-market activities including risk management.
• Deliver end-to-end regulatory inspection strategy and management.
• Manage relationships with defined stakeholder groups and senior leaders in R&D for the strategic development and delivery of a GxP risk-based, robust quality assurance program and quality management activities.
• Lead or participate in investigations of critical quality issues and ensure timely reporting to relevant authorities where applicable.
• Lead training for colleagues and business stakeholders.
• Support or lead the development and/or revision of QA processes, projects, and tools.
• Generate simple solutions to complex challenges with a solutions-focused attitude.

Qualifications

• Bachelor‚Äôs degree required; Master‚Äôs degree preferred.
• 10+ years of experience in pharmaceuticals or a related life-science industry.
• Thorough understanding and experience of GxP (GVP and GCP) and quality assurance/management.
• Strong collaborative, influencing, and interpersonal skills; curious to understand the business environment.
• Excellent analytical, written, and oral communication skills.
• Proficient in written and spoken English.
• High ethical standards, trustworthy, operating with absolute discretion.
• Skilled at managing and using technology; curious regarding AI.
• Ability to maintain and build professional networks with stakeholders.
• Experience in managing regulatory health authority GxP inspections.

Desirable

• Project management
• Key Account management
• Experience in Six Sigma/Lean/Process improvement tools
• Quality and Audit expertise