Principal Quality Lead
Core
Design and implement risk-based Quality strategies, lead audits, manage regulatory inspections, and draw compliance conclusions for molecules in development and post-approval products.
Role type
Principal Quality Lead (Pharmaceutical/Regulatory)
Builds
Quality Assurance strategies, audit methodologies, and compliance evidence for Health Authorities
Domain
Pharmaceutical industry, Clinical Trials, Pharmacovigilance, Regulatory Compliance
Deliverable
client delivery
Required skills
GxP regulations expertise, audit leadership, risk assessment, stakeholder communication, inspection management, strategic planning, mentorship
Preferred skills
Data analytics, regulatory change management, global matrix organization experience, complex problem solving
Technologies
Data visualization tools, audit management systems
Responsibilities
Design and implement Quality Strategies, Define Audits and Methodology, Perform and Lead Audits, Issue Management, Quality Conclusion Drawing, Health Authority Inspections, PDQ Goals and Initiatives, Expertise and Mentorship
Seniority
Principal, hands-on IC with strategic leadership
