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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Ensures continuous quality improvement through effective management and oversight of Audits and Inspections
- Facilitates ongoing quality improvement measures through communication of audit & Inspection intelligence and compliance guidance/training
- Leads, educates, mentors, and develops the team within the function to ensure competence and confidence in developing to become subject matter experts
- Ensures that reporting, review and analysis of Findings from Audits and Inspection and CAPAs are performed efficiently and in compliance with global regulations, legislation and PrimeVigilance requirements
- Manages a team that manages audit and inspection findings and observations and their associated corrective and preventative action plans (CAPAs)
- Manages and maintains the electronic quality management system (EG-QMS) Audits module -CAPA Management
- Performs periodic trending of Findings across the company, providing insights into the potential causes of trends
- Fosters a culture of quality within the organization as led by members of the Quality Leadership Team
- Participates in audits and inspections, follow-up of findings and completion of client questionnaires and RFP/RFI
- Acts as a Subject Matter Expert and client point-of-contact for Quality
- Collaborates with operational personnel to ensure effective root cause analysis and writing/delivery of appropriate CAPA Plans
- Develops and delivers training on related topics
Requirements
What you’ll need- A university degree in a healthcare discipline or equivalent scientific area
- Substantial experience in pharmaceutical/biotechnology pharmacovigilance with a in depth understanding of GVP/GCP-related Quality Management and Assurance
- Sound knowledge of international regulations related to Pharmacovigilance and Medical Information
- Experience of participating in audits and inspections
- Ability to lead, mentor, and develop teams
- Excellent communication and facilitation skills within a global organization
- Proactive and self-motivated with strong organizational and planning abilities
- Excellent problem-solving and decision-making skills
- Attention to detail and commitment to high standards
- Ability to analyze data and prepare detailed reports
- Knowledge of quality management principles and practices
Benefits
Comp & perks- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality managementauditsinspectionsCAPA managementdata analysisreport writingroot cause analysistraining developmentpharmacovigilanceGVP/GCP compliance
Soft Skills
leadershipmentoringcommunicationfacilitationorganizational skillsplanningproblem-solvingdecision-makingattention to detailproactive attitude
