Director, Quality, Program Management

Job Summary

The Director of Quality Program Management is a leadership position reporting into Sr. Dir, Quality Assurance, Contract Manufacturing.

The Director of Quality - Program Management is responsible for leading and directing our quality program initiatives across West Contract Manufacturing sites.

Key responsibilities include developing and executing on the quality strategy, overseeing global quality programs and implementing strategies to support business objectives.

This role involves cross-functional / site collaboration, and continuous improvement efforts to standardize and deploy best in class quality processes, drive cost saving / avoidance programs based on cost of quality definitions and trends and centrally coordinating the standardized deployment of quality data management and reporting across all CM sites.

Leadership capacity to effectively engage with local and global leaders to deliver on global solutions and innovation is a key component of this role.

Essential Duties and Responsibilities :

• Leads, develops and executes a strategy for quality program selection, tracking and action implementation this shall include a governance structure to drive communication, commitment, alignment and execution
• Develop the overall CM Quality Strategy with the Sr. Dir, Quality Assurance, CM supporting the overall strategic vision and goals of the CM organization.
• Establish a program for site assessment and development and working with sites develop strategies to improve quality and operations processes.
• Lead and / or facilitate Continuous Improvement, Kaizen and Risk Assessment events as required, help sites / teams with implementation of develop plans of quality / process improvement.

Lead risk reduction exercises. Identify best practices and ensure roll out to relevant sites.

• Leads, develops and executes a strategy for site and global Quality Oversight activities including Quality Management Review, Key Performance Indicators and Lean / Six Sigma processes such as Hoshin Kanri / Gemba / Kamishibai / Value Stream Mapping / Kaizen / Poka-Yoke.
• Define and monitor key performance indicators (KPIs) for quality, preparing detailed reports for executive leadership and CM Operating Reporting.
• Coach and direct teams to apply correct approach / DMAIC tools for improvement projects. Train out when needed and lead by example as required.
• Lead the identification of risks and opportunities for improvements in quality practices across the sites within CM Operating Unit, and then work with all levels within the organization including SMEs in leading, establishing and executing a strategy for improvement.
• Other duties as assigned based on business needs.

Basic Qualifications :

• Bachelor’s Degree in either pharmacy, chemistry, biology or equivalent.
• Significant experience (10+ years) in medical device / pharmaceutical manufacturing, quality assurance, regulatory affairs, or a related field.
• Experience in regulatory compliance management, including familiarity with FDA and other regulatory agency requirements.
• Proven track record of implementing process improvements and ensuring compliance with regulatory standards.

Preferred Knowledge, Skills and Abilities :

• Regulatory Skills : In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines, and other relevant regulatory requirements.
• Leadership Skills : Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
• Project Management Skills : String project management skills with the ability to influence without authority across multiple locations, regions and cultures
• Communication Skills : Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
• Analytical Skills : Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
• Strategic Vision : possess a profound strategic vision and robust leadership abilities to promote best practices in quality management and continuous improvement.
• Ethical Standards : Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.
• Self-motivated with a proactive attitude and the ability to work effectively.

Travel Requirements :

Must be able to travel up to 25% of the time.

Physical and Mental Requirements :

No special physical or mental requirements outlined

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