Senior Manager Quality Assurance & Complaint Intake

Senior Manager Quality Assurance & Complaint Intake

Alcon

Warsaw, Poland

As Senior Manager Quality Assurance & Complaint Intake you will be responsible for managing all elements of the quality technical complaints and adverse event day to day processes including intake, follow up, triage and system entry necessary to comply with local and international regulations, guidelines, and applicable directives. Help develop and execute strategies for Complaint handling in EMEA and serve as a partner with the affiliates and distributor markets to best support internal and external customers in relation to product complaints. Responsible for managing vigilance operational process in order to follow deadlines of Health authority submissions, ensuring compliance with Alcon global/local procedures.

In this role, a typical day will include:

• Create and maintain a high performance collaborative QAC team with focus on customer needs and compliance to handle complaints from the EMEA region;
• Engage and motivate QAC intake team through adequate training and effective communication, providing feedback to direct reports through one-to-one discussions, performance reviews, recognition and coaching;
• Supervise and provide leadership to people managers and remote direct reports, To ensure alignment with organizational goals;
• Foster development and growth of direct reports and the team leader, ensure and support the team leader in developing their respective subordinates;
• Serve as QRA community lead for associates based in the AGS Warsaw office, being a matrix manager for AGS RA associates based in Warsaw;
• Lead and contribute to EMEA-level projects within the QRA organization, driving regional initiatives and supporting cross-functional objectives;
• Engage in, lead or support as appropriate, process improvement initiatives or projects to enhance the complaints process;
• Develop and implement team-level strategies to achieve organizational objectives and drive performance improvements;
• Design and execute succession planning initiatives to ensure business continuity and prepare for future leadership needs;
• Creating and delivered comprehensive improvement plans, focusing on operational efficiency and long-term growth;
• Manage data collection, data entry, processing, documentation, reporting and follow-up of all technical product complaints and adverse event reports for all Alcon products from healthcare professionals, patients, internal Alcon personnel, clinical trials, non-interventional studies, customer-oriented marketing programs, literature, spontaneous reports, etc. in a timely manner per SOPs, regulations, and directives;
• Assist with triages from all sources for quality technical complaint, Adverse Event, request for refund, request for replacement product and request for credit;
• Acts as delegate for Regional Director for Complaints handling as needed;
• Maintain a substantial and thorough knowledge of company policies and procedures, departmental processes, and associated work instructions, evolving local and international regulations, guidelines and applicable directives in relation to complaint handling;
• Lead audit preparation activities, facilitate, manage and close out any audit findings, ensuring all corporate requirements are met and robust CAPAs implemented;
• Ensure continual Quality System Compliance by adherence to established and evolving Alcon and regulatory requirements;
• Responsible for creating and maintaining regional training and knowledge base materials.

WHAT YOU'LL BRING TO ALCON:

• 2 years of experience as a direct people manager (managing team leads or managers);
• Experience in international environment;
• Demonstrated experience of successfully leading an organization or project of high impact.

Education:

• Minimum Required: Master’s degree;
• Preferred Level: Master’s degree or equivalent, technical of life science background.

Skills:

• Fluent in English both spoken and written is a requirement. Minimum of B2 (CEFR) proficiency when covering also local language communications;
• Computer literacy with standard software platforms Experience in people management/leading teams.

Key Competencies/Behaviours:

• Effective communicator and ability to work with a variety of departments and regulatory bodies;
• Demonstrates the Company’s Values and Behaviors;
• Excellent communications, interpersonal and negotiation skills, people-oriented;
• Quality and focus oriented;
• Computer skills;
• CI approach.

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