Job Opportunity
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.
Requirements:
* 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.