Quality Assurance Associate Director, EPM

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 29 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.

• Implement, manage and lead local QA teams, both consultants and employees.
• Lead / manage regional and local Health Authority interactions, queries and inspections.
• Develop, implement and maintain Medison Quality Management Systems (QMS) ensuring that GxP and all other compliance obligations are successfully met, both regionally and locally.
• Ensure that Corporate Procedures and Standards are properly deployed into the local QMS and managed accordingly. 
• Ensure GxP training programs are implemented and maintained.
• Oversee and implement a robust Vendor Management and oversight program, suitable for an organization which operates an outsourced model.
• Prepare and conduct self-inspections and audits
• Manage any deviations, corrective and preventive actions and change controls that may arise internally or via customer and vendor channels.
• Escalate any suspected deficiencies to key Management within the EPM Management structure.
• Implement an appropriate management review system, ensuring that any trends are escalated and managed appropriately.
• Gather, maintain and communicate Key Performance Indicators (KPI`s) for quality assurance in accordance with corporate QA guidelines and local needs.
• Ensure third party Vendors or Business Partners are properly qualified, monitored and processes are compliant (e.g. storage, distribution, late-stage customization, etc.). ▪
• Support in negotiation of relevant agreements including but not limited to Quality Technical Agreements (QTA) for Vendors and Suppliers as requested.
• Coordinate local recalls in collaboration with partners and Medison management
• Ensure that Global QA and Local Business leadership are kept informed of all relevant activities
• Work in partnership with other departments / functions to ensure proper support to product launches and achievement of commercial timelines.
• Manage multiple Supply models across different territories and products across the EPM region,     ensuring compliance with key legislation is maintained during supply.
• Lead the Quality Assurance function, ensuring that key processes are in place to compliantly supply   both EU and non-EU markets in the EPM region.
• Ensure that a proactive approach is taken to license management, overseeing all activities relating to both acquiring and maintaining key regional and local licenses in both Switzerland and the EPM region.
• Manage regional and local resource planning for the QA organization, ensuring that key talent is recruited regionally and locally as required.
• Drive compliance within the EPM region, ensuring adherence to regional and local legislation

The ideal candidate for the Associate Director of Quality Assurance will be a driven, autonomous, and seasoned quality leader, responsible for ensuring robust GDP and compliance systems are in place to meet both regional and local regulatory requirements across the EPM region, as well as internal Medison Quality Assurance and Regulatory Affairs standards and policies.

• Master’s degree in a scientific discipline such as Pharmacy, Chemistry, or Biology
• Minimum of 10 years’ experience in the pharmaceutical industry, including in a similar role
• Strong collaborator with a team-oriented mindset.
• Proven ability to work effectively within cross-functional teams.
• Strong leadership skills
• Strong interpersonal skills with a proven ability to build and sustain professional, trust-based relationships
• Thrives in fast-paced, evolving environments and demonstrates adaptability and resilience.
• Strong communication skills
• Proficiency in English is required; additional language skills are considered an asset