
Global Quality Leader
1 week ago
The Senior Director of Global Quality will oversee the development and maintenance of quality standards, ensuring effective oversight and team management.
Key Responsibilities:- Lead strategic planning and goal setting to align with the organization's vision.
- Manage staff resources, including hiring strategies and candidate assessments.
- Oversee staff development, including onboarding, performance reviews, and career growth opportunities.
- Collaborate with leadership teams to discuss strategy and quality metrics.
- Develop and implement process improvement initiatives and champion innovation for quality objectives.
- Contribute to policy development and ensure compliance with regulations and best practices.
- Integrate quality risk management in processes where applicable.
- Represent senior management at quality forums and during regulatory inspections.
- Strategic leadership and technical expertise in quality management systems, CSV, and quality standards.
- Act as primary business process owner and subject matter expert for quality management systems.
- Experience in implementing new features and collaborating with IT teams.
- Assign super-users and SMEs for quality management systems and lead operational and quality metrics development.
- Oversee data stewardship and support inspection and audit activities.
- Serve as escalation point for significant issues to executive leadership.
- Participate in governance and oversight of system vendors, including issue management.
- Review and maintain policies and artifacts, providing guidance on test failures.
- Oversee reviews and approvals for equipment qualification artifacts and testing results.
- Develop and implement best practice quality strategies and policies.
- Champion quality awareness within the organization.
- Lead governance activities and facilitate quality oversight forums.
- Ensure reporting of quality-related metrics to support continuous improvement.
- Oversee the quality event portfolio and provide SME guidance and support for root cause analysis and CAPA development.
- Collaborate with leaders to define quality system metrics (KQIs/KPIs) for measuring QMS health.
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