R&D Quality Manager (Medical Devices and/or Combination Products)

Role Overview

Provide quality assurance expertise to operational activities in development and research organizations to ensure compliance with regulatory requirements and quality standards. Manage projects and processes to assure compliance with GxP regulations.

What You Will Do

Support maintenance of regulatory-required files, generate Quality Plans, and assist with health authority inspections. Identify quality issues and develop corrective and preventative action plans. Manage quality aspects of projects and activities, including third parties and analytical instruments.

Why It Might Be a Fit

Demonstrated leader of specific GxP, with sufficient financial knowledge and role model of Sandoz culture, values and behaviors.

Requirements

• Work Experience: Functional Breadth, Critical Negotiations, Project Management, Collaborating across boundaries
• Skills: Agility, Analytical Development, Audit Management, Auditing, Business Partnering, Change Control, Continuous Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, QA (Quality Assurance), Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Six Sigma, Sop (Standard Operating Procedure), Technological Expertise

Benefits

• Equal Opportunity Employer
• Diverse environment
• Reasonable accommodation for individuals with disabilities