Senior Manager, Global Quality
We are seeking an experienced Senior Manager of Global Quality to lead and develop a world-class HealthTech quality organisation. This role is responsible for driving a quality-first culture across multiple manufacturing sites worldwide while ensuring adherence to regulatory standards and delivering high-quality outcomes for customers and partners.
About the Role
The ideal candidate is a strategic leader with a strong operational mindset and a customer-oriented approach. They will excel at building relationships across regions, guiding cross-functional teams, and driving continuous improvement. This position requires a proven track record of managing complex quality systems in a regulated environment, including significant experience with FDA certification and compliance activities.
Key Responsibilities:
* Develop and execute a global quality strategy aligned with business objectives.
* Collaborate with regional and site leadership to identify gaps and implement action plans.
* Lead global quality forums to share best practices, resolve issues, and enable decision-making.
* Establish and maintain quality management systems and industry certifications (e.g., MDSAP, EU MDR).
* Define annual quality objectives and key performance metrics to foster a culture of excellence.
* Promote an "audit-ready" environment and oversee global regulatory audit programs.
* Conduct Quality Management Reviews with executive and site leadership teams.
* Lead the 8D corrective action process and ensure effective closure of quality issues.
* Recruit, develop, and mentor quality team talent across global locations.
* Provide leadership for special projects and cross-functional quality initiatives.
Required Skills and Experience:
* 10–12 years of experience in quality management functions such as Quality Assurance, Quality Systems, Validation, Design Quality, or Manufacturing Quality.
* Minimum 5 years of experience conducting internal or external audits.
* Strong understanding of FDA, ISO, RAC, and CQA standards and regulatory requirements.
* Experience managing global, multi-site teams.
* Proven ability to drive cultural transformation and embed quality principles.
* Proficiency in data analysis and reporting (Microsoft Office suite).
* Strong relationship-building, communication, and influencing skills.
* Willingness to travel internationally (approximately 15%+).
Education & Certifications:
* Bachelor's degree in Engineering or a related Science discipline required.
* Preferred certifications: RAC (US), CQA, ASQ, or ISO/RABSQA Auditor.