Sr. Manager QA APL & GEM EMEA

Alcon; Freiburg; On-site; CHF 120,000 - 180,000; Full time

Job summary

Alcon is seeking a Quality & Regulatory Affairs leader to oversee all QA activities at the country/cluster level. You will ensure compliance with ISO13485, GDP, and other regulatory requirements, acting as Qualified Person for APL and guiding continuous improvement across QA processes.

The role includes managing audits, CAPA, risk management, and collaboration with leadership to uphold high standards of quality and regulatory compliance for medical devices and pharmaceuticals.

Qualifications

• BSc degree in a scientific or engineering discipline.
• 5 years’ experience in the medical device or pharmaceutical industry.
• 3 years of QA management experience including comprehensive knowledge of ISO13485.

Responsibilities

• Act as Qualified Person for APL and maintain compliance with quality requirements.
• Lead QA activities and ensure regulatory and quality system compliance (ISO13485, GDP, MDR if applicable).
• Develop and execute strategies for continual quality oversight of APL and Representative Offices.
• Coordinate audits with Health Authorities and Notified Bodies and manage CAPAs and root-cause investigations.

Skills

QA management

Regulatory compliance

People management

Education

BSc in science or engineering

Job description

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

This role is part of Alcon's Quality & Regulatory Affairs function, to lead all Quality related activities at the country/cluster level, ensuring that the area of responsibility is in compliance with applicable regulatory standards and quality system requirements. The position has accountability to develop and execute strategies for the continual improvement of Quality oversight of APL and Representative Offices.

In this role, a typical day will include:

• Promote a strong Quality Culture and awareness of regulatory and customer requirements throughout the affiliate/cluster. Drive awareness of the Quality System as a strategic platform for the business. Engage with the Leadership and functional teams to assure high standards of compliance to the regulatory and quality system requirements.
• Engage, motivate and lead QA personnel through adequate training and effective communication, providing feedback to direct reports through one to one discussions, performance reviews, recognition and coaching.
• Perform the duties as Quality Management Representative in country to ensure that a Quality Management System (QMS) is established, documented, implemented, maintained, reviewed and improved. This must occur in accordance with the currently published applicable Quality System Standards and regulations i.e. ISO/EN ISO 13485, EU Medical Device Regulation (if applicable) and duties as Responsible Person for wholesale storage and distribution according to GDP requirements (if applicable).
• Ensure that products comply with market authorization and GMP requirements and are received, stored, handled, released, distributed and transported according to regulatory requirements including but not limited to ISO 13485, EU-MDR (if applicable to the region), GDP and relevant local requirements. Review documentation and approve incoming batches of medicinal products and /or medical devices, product returns and annual product quality reviews as required per local market.
• Ensure that processes and procedures needed for an effective Quality System in are established, implemented, optimised and maintained, including but not limited to, self inspections, supplier qualifications and monitoring, CAPA process, management review, change control, risk management, Complaint handling, Quality Planning and SOP compliance. Initiate remediation activities as necessary, to ensure ongoing compliance.
• Gather, maintain and report key quality indicators for the country/cluster, and promote process improvements through the use of lean methodology, self inspections, CAPA/non-conformance system and feedback process (complaints)
• Lead audit preparation activities, facilitate, manage and close out external audits by Health Authorities and Notified bodies (if applicable to the affiliate), ensuring all corporate requirements are met and robust CAPAs implemented.
• Manage and provide guidance to non conformance investigations ensuring formal structured approach to root cause analysis and problem solving, ensuring adequate corrective actions and prevention plans are implemented.
• Ensure that all GxP suppliers are adequately qualified and monitored, and processes are compliant with Alcon Quality requirements (e.g. warehouse, distribution, redress/relabeling) and local regulations if applicable.
• Ensure appropriate and timely escalation of quality events to management.
• Manage market actions (FSCAs, recalls, etc.) and report to the Health Authority in compliance with Corporate QA requirements and local regulations.
• Ensure continual Quality System Compliance by adherence to established and evolving Alcon and regulatory requirements. All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

For APL:

• Act as Qualified Person for APL to:
• Maintain the trading license
• Ensure communication with Swiss Medic
• Ensure products sold from APL meet Quality requirements
• Act as liaison with GxP regulatory agencies on behalf of APL and the Representative Offices
• Ensure that appropriate quality agreements are in place with APL product consignment holders to include product expiry monitoring and effectively manage appropriate agreements between APL, ESO (External Suppliers Organization) and other Alcon affiliates and manufacturing sites where required
• Support the business to assess current distributors and where necessary evaluate new ones.
• Oversee all Quality Systems for warehousing, distribution, device repair, technical support, and complaint handling for the Export markets.

WHAT YOU’LL BRING TO ALCON

• BSc Degree in a Scientific or Engineering discipline or related field
• 5 years’ experience in the medical device or pharmaceutical industry
• 3 years of QA management experience including comprehensive knowledge of ISO13485 or similar
• 3 Years people management experience
• Any other specific local country qualification requirements must also be met

Preferred Qualifications

• Supply Chain or finished product distribution experience

HOW YOU CAN THRIVE AT ALCON

• Manage your own workload and schedule while hitting your set targets
• Collaborate with teammates to share best practices and learnings as work evolves
• See your career like never before with focused growth and development opportunities

Alcon Careers

See your impact at alcon.com/careers