Position Summary
The Director of Quality - Multi-Site will provide strategic leadership, direction, and oversight of Quality operations across multiple manufacturing and/or development sites. This role ensures that all sites meet regulatory compliance, maintain consistent quality standards, and drive continuous improvement initiatives. The Director will collaborate with cross-functional teams, providing quality leadership to align processes, systems, and culture to company objectives while ensuring compliance with FDA, ISO 13485, and other applicable global regulations.
Key Responsibilities
Strategic Quality Leadership
- Develop and implement a strategic quality vision for all sites, ensuring alignment with company goals and regulatory requirements.
- Standardize and harmonize Quality Management System (QMS) processes, policies, and procedures across multiple sites to ensure consistent application and compliance.
- Serve as the senior quality leader for all multi-site operations, promoting a culture of quality, accountability, and continuous improvement.
- Collaborate with executive leadership to define quality-related strategies, objectives, and priorities for multi-site operations.
Regulatory Compliance & Audits
- Oversee compliance with FDA, ISO 13485, EU MDR, and other applicable quality and regulatory standards across all sites.
- Lead and coordinate preparations for internal, external, and regulatory audits; ensure timely resolution of audit findings and implementation of corrective actions.
- Provide leadership and support during regulatory inspections at any site, serving as the key point of contact for quality matters.
- Monitor and manage changes in regulatory requirements to ensure the company remains compliant across all locations.
Quality Systems Management
- Drive the effectiveness of Quality Systems, including CAPA, document control, change management, non-conformance management, and risk management processes across all sites.
- Lead the standardization and optimization of quality processes to ensure alignment, efficiency, and compliance.
- Establish and monitor Quality Metrics/KPIs to track performance across all sites and drive improvements.
- Oversee the effectiveness of Management Review processes to ensure leadership alignment and continuous QMS improvements.
Multi-Site Collaboration & Oversight
- Provide leadership, coaching, and mentorship to site Quality Managers and their teams, ensuring a consistent approach to quality practices and performance.
- Establish a structured approach for communication, collaboration, and knowledge sharing between sites to promote best practices.
- Partner with Operations, R&D, Manufacturing, and Supply Chain teams to ensure seamless integration of quality processes into all phases of product development and production.
- Act as a bridge between corporate leadership and site-level teams, ensuring company-wide quality objectives are understood and executed.
Continuous Improvement
- Champion continuous improvement initiatives to reduce quality risks, improve operational efficiencies, and enhance product quality.
- Drive the implementation of Lean, Six Sigma, and other process improvement methodologies to standardize processes across sites.
- Analyze quality data and trends to identify opportunities for process improvements and cost savings.
Product Development & Risk Management
- Provide quality oversight for new product development, ensuring proper design controls, risk management, and regulatory compliance.
- Ensure robust risk management strategies (e.g., FMEA, Hazard Analysis) are implemented and maintained across all product lines and sites.
- Collaborate with teams to resolve non-conformances, CAPAs, and customer complaints, driving resolution and prevention across sites.
Leadership & Talent Development
- Build, mentor, and lead a high-performing quality team across all sites.
- Ensure appropriate training and development plans are in place for quality staff, fostering a culture of leadership and excellence.
- Promote accountability, ownership, and collaboration across all quality functions and teams.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Quality Management, or related technical field.
- 10+ years of experience in Quality leadership roles within a regulated industry (e.g., medical devices, pharmaceuticals).
- Multi-site quality leadership experience, including developing and implementing global quality systems and strategies.
- In-depth knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR, and other applicable global regulations and standards.
- Strong experience with audits, regulatory inspections, and QMS improvement initiatives.
- Demonstrated success leading cross-functional teams, implementing process improvements, and harmonizing quality systems.
- Proven leadership skills, with experience mentoring and developing quality teams.
- Proficiency in quality tools and methodologies, including Lean, Six Sigma, and statistical analysis techniques.
- Excellent communication, organizational, and problem-solving skills.
Preferred Qualifications
- Master's degree in a relevant field or an MBA.
- Certified Quality Engineer (CQE), Lead Auditor, or Six Sigma Black Belt certification.
- Experience with global operations and international regulatory compliance.
- Experience with ERP/QMS tools such as SAP, MasterControl, or similar platforms.
Benefits
- Competitive salary and executive-level performance bonuses
- Comprehensive health, dental, and vision benefits
- 401(k) with company match
- Opportunities for professional development and career advancement
- Dynamic and collaborative work environment
