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Senior Quality Assurance Manager
Medison Pharma. Lead the Quality Assurance function in Israel, including management of the local QA team and pharmacist team .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in Quality Assurance within the pharmaceutical industry, with a strong focus on compliance with GxP requirements and regulatory standards. Proven leadership capabilities in managing QA teams and developing Quality Management Systems.
Highest-signal resume keywords
Quality Assurance LeadershipGxP CompliancePharmaceutical Quality SystemsPeople ManagementRegulatory Requirements Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Quality Management System DevelopmentDeviation ManagementCAPA ManagementChange Control ManagementQuality Risk ManagementInternal AuditsQuality KPIs CommunicationVendor ManagementQuality Technical Agreements NegotiationControlled Document Approval
Soft Skills
Strong LeadershipCollaborationInterpersonal SkillsCommunication SkillsAbility to Thrive in Fast-Paced Environments
Industry Keywords
Pharmaceutical IndustryGxP RequirementsGDPQuality AssuranceRegulatory ComplianceHealth Authority InteractionsQuality Records ManagementEmployee Qualification ProgramsSOPsQuality Trends Analysis
About the role
Key responsibilities & impact- Lead the Quality Assurance function in Israel, including management of the local QA team and pharmacist team
- Participate in the Israel Tech Ops Leadership Team
- Develop, implement, and maintain the local Quality Management System (QMS)
- Ensure compliance with GxP requirements, corporate procedures, standards, and applicable regulatory requirements
- Lead quality interactions with the local Health Authority, including queries and inspections
- Ensure accuracy, quality, and appropriate approval of quality records and controlled documents
- Implement and maintain GxP training and employee qualification programs
- Manage deviations, CAPAs, change controls, and quality risk management according to applicable SOPs
- Conduct periodic management reviews and address quality trends and risks
- Gather, maintain, and communicate QA KPIs
- Develop and oversee the vendor management program
- Review and approve subcontracted activities that may impact product quality
- Participate in negotiating and managing Quality Technical Agreements and other quality-related agreements
- Plan and conduct internal audits and self-inspections and ensure corrective actions are implemented
- Coordinate local recalls with partners and Medison management
- Keep Global QA and Local Business Leadership informed of quality activities and issues
- Collaborate with cross-functional teams to support product launches and commercial timelines
Requirements
What you’ll need- Academic degree in Pharmacy or another relevant scientific field
- Minimum 10 years of experience in the pharmaceutical industry, including experience in a similar Quality Assurance role
- Minimum 5 years of people management experience with strong leadership capabilities
- Ability to operate independently and lead the Quality function with a high level of ownership
- Ability to ensure compliance with regional and local regulatory requirements and Medison quality standards
- Strong knowledge of GDP and pharmaceutical quality and compliance systems
- Strong understanding of regional and local regulatory requirements and quality standards
- Strong collaboration and interpersonal skills, with the ability to build trusted relationships and work effectively across functions
- Strong communication skills
- Ability to thrive in a fast-paced and evolving environment
- Fluent English; additional languages are an advantage
Benefits
Comp & perks- Remote Israel Hybrid work arrangement
- Full-time employment