Quality Manager – Quality Assurance
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 services, committed to enabling customers to make the world healthier, cleaner, and safer. The organization delivers innovative solutions across life sciences, healthcare, environmental protection, and clinical research. Its quality teams play a critical role in ensuring product safety, regulatory compliance, and operational excellence, contributing to life-changing scientific advancements worldwide.
Job Overview
The Quality Manager will lead quality operations within a Good Manufacturing Practice (GMP) environment, ensuring regulatory compliance, operational efficiency, and continuous quality improvement. This role provides strategic oversight of manufacturing operations, laboratory activities, and quality systems while driving a strong culture of quality excellence across cross-functional teams. The position also involves leadership responsibilities, regulatory compliance management, and implementation of quality management processes aligned with global standards.
This opportunity is ideal for experienced quality professionals seeking to lead quality assurance initiatives and deliver high-impact outcomes in a regulated environment.
Key Responsibilities
Oversee the implementation, maintenance, and performance of the Quality Management System (QMS) in accordance with ISO 9001 standards.
Lead and manage QA/QC teams at the Bangalore site, ensuring effective team performance and development.
Participate in site leadership initiatives and integrate quality strategies into overall operational objectives.
Interpret and implement regulatory requirements into operational processes and quality deliverables.
Establish and maintain closed-loop Corrective and Preventive Action (CAPA) processes to monitor performance and implement improvements.
Conduct periodic QMS assessments to ensure regulatory compliance and recommend process enhancements.
Review manufacturing processes, validation plans, and quality reports for regulatory alignment.
Communicate quality and compliance requirements effectively across departments and stakeholders.
Implement process improvements and training initiatives to maintain compliance standards.
Drive quality culture initiatives and promote organizational adherence to integrity, innovation, and operational excellence.
Ensure strong documentation practices including document control, change management, deviations, and validation processes.
Support risk management activities and continuous improvement initiatives.
Experience Required
Advanced degree with a minimum of 6 years of experience in a GMP or regulated environment, OR
Bachelor’s degree with at least 8 years of relevant experience in quality assurance or quality management within regulated industries.
Minimum 3 years of leadership or team management experience in quality operations.
Experience managing quality systems, regulatory compliance, and cross-functional teams in manufacturing or laboratory environments.
Educational Qualifications
Bachelor’s or Advanced Degree in Chemistry, Biology, Engineering, Pharmacy, or a related discipline.
Professional certifications such as ASQ, Six Sigma, or equivalent quality certifications are preferred.
Required Skills and Competencies
Strong understanding of quality systems including document control, change control, deviations, validation, and CAPA processes.
Proven leadership experience in quality operations and team development.
Strong project management and cross-functional collaboration capabilities.
Excellent analytical and problem-solving skills with data-driven decision-making ability.
Effective written and verbal communication skills, including technical documentation expertise.
Knowledge of risk management tools and continuous improvement methodologies.
Proficiency in quality management software and document management systems.
Strategic mindset with strong stakeholder engagement and negotiation skills.
Ability to manage ambiguity, mentor teams, and drive organizational quality initiatives.
Keys to Success in the Role
Manage quality requirements throughout the product lifecycle across research and regulated environments.
Ensure adherence to regulatory standards and company policies.
Promote continuous improvement and best practices in quality assurance.
Represent the quality function internally and externally with professionalism and precision.
Work Environment
Office-based work environment with exposure to standard office equipment.
Collaboration with cross-functional and global teams.
No travel requirements for this role.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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