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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management, Compliance, and Risk Management within regulated environments, with a strong focus on Continuous Improvement and effective stakeholder collaboration. Proficient in analyzing quality metrics, managing CAPAs, and preparing for audits and inspections.
Highest-signal resume keywords
Quality ManagementRisk ManagementRoot Cause AnalysisCAPA ManagementAudit Readiness
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Metrics AnalysisDeviations ManagementCorrective ActionsPreventive ActionsRegulatory Compliance
Soft Skills
Analytical SkillsProblem-SolvingCommunication SkillsStakeholder ManagementCollaboration
Certifications & Qualifications
Professional Certification in QualityProfessional Certification in Risk ManagementProfessional Certification in Compliance
Industry Keywords
PharmacovigilanceDrug SafetyClinical ResearchRegulated EnvironmentInspection Readiness
About the role
Key responsibilities & impact- Monitor agreed quality and compliance metrics, identifying risks, trends and outliers and escalating potential non-compliance or areas requiring further action
- Provide focused review and analysis of metrics for specific clients or projects when required
- Support operational teams with the management of Quality Events, including deviations, Corrective and Preventive Actions (CAPAs) and audit findings
- Support investigations and Root Cause Analysis (RCA), helping to identify underlying causes and appropriate corrective and preventive actions
- Assist operational teams with audit and inspection readiness, including preparation for and support during client audits and regulatory inspections
- Support the effective management and resolution of audit and inspection findings, working collaboratively with relevant stakeholders
- Contribute to system and process optimisation initiatives, using quality data and operational insight to identify opportunities for improvement
- Work cross-functionally to promote strong risk awareness and a culture of quality, compliance and continuous improvement
Requirements
What you’ll need- Bachelor’s degree in life sciences, pharmacy, healthcare, law, business, quality, risk management, or a related field
- A professional certification in quality, risk management or compliance is an advantage
- Relevant experience within Pharmacovigilance, Drug Safety, Quality, Compliance or another regulated pharmaceutical or clinical research environment
- A good understanding of regulated operational processes and associated quality and compliance requirements
- Experience working with quality metrics, deviations, CAPAs, audit findings and Root Cause Analysis
- Exposure to audits, inspections, compliance reviews or inspection-readiness activities
- Strong analytical and problem-solving skills, with the ability to identify trends, outliers and areas of potential risk
- The ability to work collaboratively with operational teams to investigate issues and develop practical, sustainable solutions
- Strong communication and stakeholder management skills, with the confidence to raise and escalate risks appropriately
- The ability to manage competing priorities and follow actions through to resolution
- A proactive approach to continuous improvement, quality and compliance
- Legal right to work in the country where the role is based
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
