Sr. Manager QA APL & GEM EMEA

About the role

This role sits within Alcon's Quality & Regulatory Affairs function and leads all quality-related activities at country or cluster level, ensuring compliance with regulatory standards and quality system requirements. It is accountable for developing and executing strategies for the continual improvement of quality oversight of APL and Representative Offices.

Key responsibilities

• Promote a strong quality culture and awareness of regulatory and customer requirements, and drive awareness of the Quality System as a strategic platform
• Engage leadership and functional teams to assure compliance with regulatory and quality system requirements
• Lead and train QA personnel, giving feedback through one-to-one discussions, performance reviews, recognition and coaching
• Act as Quality Management Representative so that a QMS is established, documented, implemented, maintained, reviewed and improved in line with ISO/EN ISO 13485 and the EU MDR where applicable, and as Responsible Person for wholesale storage and distribution under GDP where applicable
• Ensure products comply with market authorization and GMP requirements and are received, stored, handled, released, distributed and transported in line with regulatory requirements
• Review documentation and approve incoming batches, product returns and annual product quality reviews
• Establish and maintain quality processes such as self-inspections, supplier qualification and monitoring, CAPA, management review, change control, risk management, complaint handling and SOP compliance
• Gather and report quality indicators, run lean process improvements and lead audit preparation and closure of external audits by health authorities and notified bodies
• Manage non-conformance investigations with a structured root cause analysis, ensure GxP suppliers are qualified and monitored, and escalate quality events and manage market actions such as recalls
• For APL: act as Qualified Person, maintain the trading licence, liaise with Swissmedic and GxP regulators, ensure quality agreements with consignment holders cover expiry monitoring, and oversee quality systems for warehousing, distribution, device repair, technical support and complaints for export markets

Required profile

• 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
• 3 years of people management experience
• Any specific local country qualification requirements must also be met

Required skills

• Comprehensive knowledge of ISO 13485 or similar
• Preferred: supply chain or finished product distribution experience