Sr. Director, Research and Development Quality Assurance

Alcon • Johns Creek, GA

3d

About The Position

All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

Requirements

• Compliance with European Union Medical Device Regulation 2017/745
• Meet Medical Device Coordination Group 2019-07 experience requirements
• Adherence to Good Practice regulations
• Strictly following Standard Operating Procedures
• Maintaining accurate and complete documentation
• Rigorous quality control
• Completing all required training

Responsibilities

• Lead multiple departments or a large division, translating the Vice President’s vision into actionable plans and ensuring alignment with business objectives
• Ensure compliance with European Union Medical Device Regulation 2017/745 and meet Medical Device Coordination Group 2019-07 experience requirements
• Oversee quality assurance strategies, ensuring compliance with regulatory standards and driving continuous improvement across departments
• Make significant decisions within your division, approving departmental budgets and major projects
• Assure compliance of all Research & Development activities within product development and direct Research & Development personnel to execute appropriately
• Foster a culture of excellence by leading performance management, driving talent development, ensuring positive associate relations, enhancing associate engagement, recognizing achievements, and driving a strong safety culture
• Ensure all associates adhere to Good Practice regulations by strictly following Standard Operating Procedures, maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training
• Oversee and approve operational and management reviews
• Identify key quality indicators for franchise Research & Development and ensure these indicators are defined, implemented, and regularly reviewed
• Identify new standards for evaluation and ensure Research & Development policies, procedures, standards, and systems are current, comply with all applicable Corporate policies, Health/Regulatory Authority requirements, and are at least equal to industry best practices
• Provide strategic feedback and approve Quality Assurance Agreements

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed