Sr. Associate, Lifecycle Management

Alcon•Fort Worth, TX

7h•Onsite

About The Position

The Sr. Associate, Lifecycle Management (Professional Path) is part of Alcon’s Quality & Regulatory Affairs function. The role manages regulatory affairs activities related to product lifecycle management and supports compliance with local and international regulations. It works with cross-functional teams on regulatory submissions, product changes, and maintaining regulatory approvals throughout the product lifecycle. The position performs specialized tasks and independent research, prepares and submits regulatory documents, provides portfolio analyses and reports to management committees, and makes decisions within the scope of assigned tasks. It leads assigned product launch, product change, divestment, and rationalization projects; manages packaging component changes; coordinates material master and related data setup in Alcon ERP systems; and manages change control records from initiation through closure. The role is onsite in Fort Worth, Texas, on a first-shift Monday–Friday schedule, with 0–10% travel. Sponsorship and relocation are not available.

Requirements

Bachelor’s degree or equivalent years of directly related experience; alternatives listed are high school plus 10 years, an associate degree plus 6 years, or an M.S. with 0 years.
Ability to fluently read, write, understand, and communicate in English.
2 years of relevant experience.

Nice To Haves

Experience with SAP ERP systems.
Understanding of manufacturing operations, supply chain processes, and material lifecycle management.
Proficiency with BI reporting tools for data analysis, validation, and reporting solutions.
Experience with change control systems and documentation practices.
Excellent project management and communication skills.
Detail-oriented, with strong analytical and problem-solving abilities.
SAP knowledge.

Responsibilities

Perform specialized tasks and independent research to optimize lifecycle management outcomes and contribute to project goals.
Assist with preparing and submitting regulatory documents in compliance with relevant regulations.
Support cross-functional teams in meeting lifecycle management requirements and improve the efficiency and success of lifecycle management and regulatory submissions.
Provide product portfolio analyses and reports to management committees to support decision-making.
Make decisions within the scope of assigned tasks using advanced knowledge, analytical skills, and self-direction.
Follow Good Practice (GxP) regulations and Standard Operating Procedures (SOPs), maintain accurate and complete documentation, and support rigorous quality control.
Complete required training and contribute to organizational compliance and continuous improvement.
Lead assigned New Product Launch Requests (NPL), Existing Product Change Requests (EPCR), divestment, and rationalization projects.
Manage packaging component changes end to end, including artwork updates, material changes, and specification revisions.
Analyze, coordinate, and complete new material master setup and change requests in Alcon ERP systems.
Coordinate data setup activities, including costing, pricing, source lists, PIRs, and material data extension approvals, to support product launches in manufacturing.
Work with Manufacturing, Supply Chain, Finance, Quality, Sales, and other business teams to resolve master data issues in a timely manner.
Coordinate and manage change control records from initiation through closure.
Monitor open change controls and drive timely completion of action items.
Escalate overdue actions and implementation delays to management as necessary.
Maintain accurate documentation and change control records in relevant systems, including Ensure, SAP, and TrackWise.
Collaborate with Global Lifecycle Management, Quality, Procurement, Manufacturing, Engineering, and Supply Chain to ensure alignment and timely execution.