Sr. Associate, Lifecycle Management

Alcon Research•Fort Worth, TX

5d•Onsite

About The Position

The Sr. Associate, Lifecycle Management (Professional Path) is part of Alcon's Quality & Regulatory Affairs function and manages regulatory affairs activities related to product lifecycle management. The role supports compliance with local and international regulations and helps maintain regulatory approvals throughout the product lifecycle. It works closely with cross-functional teams to support regulatory submissions, product changes, and lifecycle management requirements. The position performs specialized tasks and independent research, prepares and submits regulatory documents, and provides product portfolio analyses and reports to management committees. It leads assigned product launch, product change, divestment, and rationalization projects, and manages end-to-end packaging component changes, including artwork updates, material changes, and specification revisions. The role also coordinates material master setup and changes, supporting data activities such as costing, pricing, source lists, PIRs, and material data extension approvals for manufacturing product launches. The associate coordinates change control records from initiation through closure, monitors open items, drives timely completion, escalates overdue actions or implementation delays, and maintains accurate documentation in relevant systems. The role follows Good Practice (GxP) regulations and Standard Operating Procedures (SOPs), completes required training, and contributes to compliance and continuous improvement. The role is onsite in Fort Worth, works a first-shift Monday–Friday schedule, and requires 0–10% travel. Sponsorship and relocation are not available.

Requirements

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

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 approach 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 in 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 assigned tasks using advanced knowledge, analytical skills, and self-direction.
Lead assigned New Product Launch Requests (NPL), Existing Product Change Requests (EPCR), divestment, and rationalization projects.
Manage end-to-end packaging component changes, including artwork updates, material changes, and specification revisions.
Analyze, coordinate, and complete new material master setup and change requests in Alcon ERP systems.
Coordinate costing, pricing, source list, PIR, and material data extension approval setup activities to support product launches in manufacturing.
Work with Manufacturing, Supply Chain, Finance, Quality, and Sales to address and resolve master data issues.
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 needed.
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.
Follow GxP regulations and SOPs, maintain complete documentation, complete required training, and contribute to organizational compliance and continuous improvement.