Senior Software Validation Lead – Regulatory & GAMP Expert

Medline; United States; Remote; USD 101.000 - 152.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) contributions

Paid time off

Zusammenfassung

Medline is seeking a leadership-level professional to guide validation projects, ensuring compliance with customer and regulatory expectations. You will design and execute validation strategies across software, processes, and facilities, coordinating with multiple teams and stakeholders to meet project goals.

The role requires deep experience with GAMP 5, FDA 21 CFR Part 820, ISO 13485, and medical device QMS environments, plus strong communication and project-management skills.

Qualifikationen

• Bachelor's degree in Engineering, Quality, Business, or Computer Science.
• At least 5 years of experience in Manufacturing, Quality or Engineering.
• At least 3 years of experience in GAMP 5 related computerized system validations.
• Direct experience in a medical device QMS environment, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and Software Validation principles.
• Knowledge of software engineering concepts and ability to lead cross-functional teams.
• Experience with project management and cross-functional collaboration.
• Experience operating in an AS400 environment.
• Travel up to 25% for business purposes.

Aufgaben

• Lead design, development, and execution of software validation plans and tests.
• Manage multiple validation projects and communicate status to customers.
• Document validation protocols and reports with professional written communication.
• Adhere to Medline policies and relevant regulatory procedures.
• Support on-site facilities and drive process improvements in validation workflows.

Kenntnisse

Software validation

Regulatory compliance

Project management

AS/400 experience

MS Word

MS Project

MS Excel

Kanban

Communication

Ausbildung

Bachelor's degree in Engineering / Quality / Business / Computer Science

Tools

MS Word

MS Project

MS Excel

Jobbeschreibung

Medline is seeking a leadership-level professional to guide validation projects, ensuring compliance with customer and regulatory expectations. You will design and execute validation strategies across software, processes, and facilities, coordinating with multiple teams and stakeholders to meet project goals.

The role requires deep experience with GAMP 5, FDA 21 CFR Part 820, ISO 13485, and medical device QMS environments, plus strong communication and project-management skills.