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Job ID 218441BR Position Title Regional QA Head EMEA Division ALCON Business Unit COMMERCIAL EMEA AL Country Switzerland Work Location Geneva Company/Legal Entity Alcon Management SA Functional Area Quality Job Type Full Time Employment Type Regular Job Description Regional QA Head EMEA
Location: Flexible within EU
The purpose for the Regional QA Head EMEA role is to drive the implementation of Country Quality organization governance and oversight processes within the region and country organizations.
Ensure on-going compliance of country organizations with applicable regulatory requirements (i.e. GMP, GDP, GCP, ISO, Vigilance).
Ensure implementation of and on-going compliance with the Novartis Quality Manual and Policies as well as Industry Best Practices. Ensure that all quality relevant processes are compliant and that non-compliance is appropriately addressed via corrective and preventive actions (CAPA) and/or escalation of issues.
Provide a strong and consistent voice in regional forums and partner with regional commercial team to identify issues and opportunities and to develop compliant business strategies and solutions.
Main Duties & Accountabilities include:
• Drive together with the Regional Commercial Leadership Team, Country Heads and the Country Quality units, the implementation of a consistent quality culture and quality organization across the Region and Countries.
• Lead and influence Quality Culture at the country level and at Regional Commercial Leadership Team.
• Lead Regional Country Quality Review at Regional Commercial Leadership Team meetings.
• Drive the implementation of the required actions.
• Deliver proper management of products throughout product lifecycle (launch of new products, market release, CAPAs, deviations, recalls, etc.).
• Lead the adoption and maintenance of applicable Quality Standards and governance processes through the implementation of the Novartis Quality Manual and Policies. Liaise effectively across Alcon organization and Novartis Country Quality organization to ensure that global processes are adequately implemented and sustained in the Countries.
• Ensure implementation of adequate training within countries for all GXP activities by supporting training activities.
• Ensure development of talent within the regional and local Country Quality units.
Alcon is the world leader in eye care and the second-largest division of Novartis. As the global leader in eye care, Alcon develops and manufactures innovative medicines and devices to serve the full life cycle of eye care needs. We offer the broadest spectrum of surgical, pharmaceutical and vision care products to treat many eye diseases and conditions.
While meeting patients’ needs in every aspect of Eyecare, the diversity of the franchise model across Alcon gives associates the opportunity to experience a commercial environment spanning medical devices, primary and secondary care and OTC.
Alcon has one mission: to provide innovative products that enhance quality of life by helping people see better. Minimum requirements The ideal candidate will have the following
• Demonstrated experience of successfully leading an organization or project of high impact
• Significant Quality Assurance experience and involvement in a related regulated industry; broad understanding of global expectations of Health Authorities in the GxP regulated area.
• Significant experience within people leadership in the medical device industry, people management experience in a matrix environment.
• Exposure to manufacturing operations and /or quality assurance, country organizations or commercial operations.
• Ability to influence and inspire the QA and commercial teams
• Priority setting against a wide range of strategic and tactical activities
• Medical Devices industry experience is essential.
‘I came for the job, I stay for the culture’