Senior Quality Assurance Manager, Israel

Description

Medison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases.

Medison has a deep expertise in local regulatory and market access know-how with uncompromising compliance excellence. It offers an affiliate-like partnership and tailored solutions for country-specific and regional commercialization, enabling emerging biotech companies to navigate local complexities and to expand their reach to patients in international markets.

Medison is rapidly growing in the international markets backed by 30 years of established operations in Israel, global infrastructure, and partnership network. Medison is headquartered in Israel, with its international markets HQ in Switzerland and commercial hubs across European Partner Markets, Americas, APAC.

Responsibilities

• Lead the Quality Assurance function in Israel, including management of local QA team and pharmacist team
• Be part of the Israel Tech ops Leadership Team
• Develop, implement, and maintain the local Quality Management System (QMS), ensuring compliance with GxP requirements, corporate procedures, standards, and applicable regulatory requirements
• Lead the quality interactions with the local Health Authority, as well as queries, and inspections
• Ensure the 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 in accordance with applicable SOPs
• Ensure periodic management reviews are conducted, identifying, escalating, and addressing relevant quality trends and risks
• Gather, maintain, and communicate QA KPIs in line with corporate guidelines and local requirements
• Develop and oversee the vendor management program, ensuring suppliers, customers, subcontractors, third-party vendors, and business partners are appropriately qualified, approved, monitored, and compliant
• Review and approve subcontracted activities that may impact product quality
• Take part of the negotiation and management of Quality Technical Agreements (QTAs) and other quality-related agreements with vendors and suppliers
• Plan and conduct internal audits and self-inspections and ensure appropriate corrective actions are implemented based on findings
• Coordinate local recalls in collaboration with partners and Medison management
• Keep Global QA and Local Business Leadership informed of relevant quality activities and issues
• Collaborate with cross-functional teams to support product launches and commercial timelines

Requirements

• 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