Alcon is looking to hire a Quality Assurance Manager to join our QA team in Panama City, Panama. You will be responsible for all Quality related activities at the country / cluster level, ensuring compliance with applicable regulatory standards, quality system requirements and company policies.
Ensure that processes and procedures needed for an effective Quality System are established, implemented and maintained, including but not limited to, self-inspections, supplier qualifications, CAPA process, management review, change control, risk management, Quality Planning and SOP compliance.
Promotes a strong Quality Culture and awareness of regulatory and customer requirements throughout the affiliate / cluster organization.
Works closely with commercial partners to drive awareness of the Quality System and Compliance as a strategic platform for the business.
Perform the duties as Quality Management Representative in country in accordance with ISO and regulatory requirements.
Manage and provide guidance to non-conformance investigations ensuring formal structured approach to root cause analysis and problem solving, ensuring robust corrective actions and prevention plans are implemented.
Gather, maintain and report key quality indicators for the country / cluster, and promote process improvements through the use of lean methodology, self-inspections, CAPA / deviations system and feedback process.
Lead audit preparation activities, facilitate, manage and close out external audits by Health Authorities and Notified bodies, ensuring all corporate requirements are met and robust CAPAs implemented.
Ensure that products comply with market authorization and GMP requirements and are received, stored, handled, released, distributed and transported according to regulatory 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 continual Quality System Compliance by adherence to established industry standards, regulatory requirements and Alcon policies.
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 regulation.
Ensure timely notification of complaints.
Staff, organize, and develop the Quality Assurance department to effectively carry out the department responsibilities.
Ensure that all GxP suppliers are adequately qualified and monitored and processes are compliant with Alcon Quality requirements (e.
g. warehouse, distribution, redress / relabeling).
Engage and motivate QA personnel through adequate training and effective communication, providing feedback to direct reports through one to one discussions, performance reviews, recognition and coaching.
University degree in Pharmacy / Chemistry / Biology, healthcare science, Engineering
Fluency in English (verbal and written)
5 years QA experience with Medical device or Pharma industry
Experience and competence with cGMP (CFR 820), GDP, ISO13485, EUMDR, US FDA, PICS and local regulatory standards
Direct interaction with Health Authorities and notified bodies
Experience managing people at remote (international) locations
3+ years QA experience in a commercial business environment
High standard of technical writing
Relocation assistance : No
Visa Sponsorship available : No