Director – Quality & Regulatory Affairs Center of Excellence (Q&RA COE)
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Category: Quality & Regulatory
Work Mode: Fully Onsite
Company: Thermo Fisher Scientific
About the Company
Thermo Fisher Scientific is a global leader in scientific research services and life sciences solutions, committed to enabling customers to make the world healthier, cleaner, and safer. The organization delivers innovative technologies, diagnostic solutions, and regulatory expertise that support healthcare advancement, environmental protection, and scientific innovation worldwide. Its quality and regulatory teams play a vital role in ensuring compliance, safety, and operational excellence across global markets.
Job Overview
The Director – Quality & Regulatory Affairs Center of Excellence (Q&RA COE) will lead the development, scaling, and strategic execution of a centralized Quality and Regulatory Affairs Center of Excellence. This leadership role focuses on strengthening compliance frameworks, reducing regulatory risks, accelerating product registrations, and improving global market access.
The position involves defining and implementing operational strategies, standardizing quality processes, driving digital transformation initiatives, and ensuring measurable improvements in audit readiness and regulatory submissions. The Director will work closely with senior leadership and global stakeholders to align quality and regulatory operations with business objectives across corporate and specialty diagnostics functions.
This is a senior leadership opportunity for experienced professionals with extensive expertise in global regulatory frameworks, quality management systems, and large-scale organizational transformation.
Key Responsibilities
Q&RA COE Strategy and Operations
Define and implement multi-year strategy and operating model for the Quality & Regulatory Affairs Center of Excellence.
Develop service frameworks across Quality Assurance, Regulatory Affairs, and digital quality initiatives.
Establish governance structures including quality councils, submission boards, and compliance forums.
Standardize processes and implement digital tools to improve regulatory efficiency and compliance outcomes.
Execute strategic initiatives aligned with corporate and business unit objectives.
Organizational Development and Leadership
Build and structure core functional teams across Quality Assurance, Regulatory Affairs, and digital quality operations.
Design competency frameworks, career development pathways, and certification programs for team members.
Recruit, mentor, and develop leadership talent while ensuring succession planning and employee engagement.
Implement training and onboarding programs to support global quality and regulatory standards.
Global Compliance and Regulatory Excellence
Ensure effective implementation of global quality standards including ISO 13485 and 21 CFR 820 Quality Management System requirements.
Lead internal audit programs and regulatory inspection readiness initiatives.
Oversee global product registrations, dossier preparation, and submission processes.
Monitor quality metrics such as CAPA, deviations, regulatory queries, change management, and labeling compliance.
Drive improvements in audit readiness, regulatory performance, and compliance outcomes.
Digital Transformation and Quality Analytics
Lead digital quality initiatives, automation programs, and data-driven analytics capabilities.
Develop integrated quality systems to improve data integrity, compliance, and operational efficiency.
Build dashboards and reporting frameworks to support informed decision-making and performance monitoring.
Stakeholder and Vendor Management
Partner with business leaders and global teams for workforce planning and operational alignment.
Develop vendor engagement strategies, service level agreements, and performance governance models.
Lead stakeholder communication and represent quality and regulatory functions in executive forums.
Provide leadership updates on compliance risks, performance metrics, and strategic initiatives.
Governance and Performance Management
Manage COE budget planning, resource allocation, and performance metrics.
Develop and publish key performance indicators and management review reports.
Drive continuous improvement programs delivering measurable business and compliance benefits.
Experience Required
Minimum 15+ years of experience in Quality and Regulatory Affairs within medical devices, in-vitro diagnostics (IVD), life sciences, or combination products.
Proven experience managing global quality management systems, regulatory inspections, and product registrations.
Demonstrated success in building and leading large-scale quality and regulatory teams (200+ professionals).
Extensive experience working with global regulatory authorities and managing compliance audits.
Strong background in risk management, process validation, design controls, and post-market surveillance.
Educational Qualifications
Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy, or a related field.
Professional certifications such as Regulatory Affairs Certification (RAC), ASQ Certified Quality Engineer (CQE/CQA), ISO 13485 Lead Auditor, or Six Sigma are preferred.
Required Skills and Competencies
Strong strategic thinking and risk-based decision-making capabilities.
Deep expertise in global regulatory standards and quality management frameworks.
Advanced leadership skills with the ability to build high-performing teams and develop future leaders.
Strong communication and stakeholder management skills, including regulatory interactions.
Vendor negotiation and contract management expertise.
Experience driving digital transformation and process optimization initiatives.
Ability to foster a culture of continuous improvement, innovation, and compliance excellence.
Work Environment
Office-based work environment with global stakeholder collaboration.
Standard Monday to Friday work schedule.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Siliguri |Illinois :
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