Impact Quality Lead
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Key Responsibilities
- GVP Quality & Compliance: Provide quality oversight of global pharmacovigilance activities, ensuring compliance with applicable GVP regulations, regulatory guidelines and internal quality standards.
- Audits & Inspections: Support and coordinate GVP audits and regulatory inspections, including inspection readiness, audit findings and remediation activities.
- Quality Management Systems: Oversee the review, development and approval of PV-related SOPs, work instructions and quality processes to ensure continued regulatory compliance.
- Deviation & CAPA Management: Identify and investigate quality deviations, conduct root cause analysis, implement corrective and preventive actions (CAPAs) and monitor their effectiveness.
- Risk Management & Continuous Improvement: Proactively identify potential compliance risks, recommend practical solutions and collaborate with cross-functional stakeholders to drive quality improvements across global PV operations. Key Requirements
- 8+ years of experience within Pharmacovigilance Quality Assurance, GVP Compliance, GVP Auditing or a closely related quality function within the pharmaceutical or biotechnology industry.
- Strong knowledge of global GVP regulations , including EMA, FDA and ICH requirements, with an understanding of pharmacovigilance quality systems and regulatory expectations.
- Demonstrated experience supporting or leading GVP audits and regulatory inspections , including inspection preparation, findings management and remediation.
- Hands-on experience with quality management systems , including SOP management, deviations, CAPAs, root cause analysis and compliance risk assessments.
- Strong analytical, problem-solving and stakeholder management skills , with the ability to independently identify compliance risks, propose effective solutions and influence cross-functional teams.
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