Quality Manager – GMP & Quality Systems
Location: Bangalore, Karnataka, India
Job ID: R-01339712
Employment Type: Full-Time
Work Mode: Fully Onsite
Function: Quality & Regulatory
Work Schedule: Monday to Friday
Work Environment: Office-Based
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is a global leader in serving science, enabling customers to make the world healthier, cleaner, and safer. Through advanced technologies, regulatory expertise, and world-class quality systems, Thermo Fisher Scientific supports life sciences research, analytical testing, diagnostics, and biopharmaceutical manufacturing across the product lifecycle.
The Quality organization plays a critical role in ensuring product safety, compliance, and operational excellence. Quality professionals collaborate globally to uphold regulatory standards while driving continuous improvement and innovation.
Role Overview
The Quality Manager will lead quality assurance operations within a regulated GMP environment, ensuring compliance with ISO 9001 and applicable global regulatory standards. This leadership role is responsible for overseeing quality systems, managing QA/QC teams, and embedding a strong culture of quality across manufacturing, laboratory, and operational functions.
As a member of the site leadership team, the Quality Manager will provide strategic quality oversight, guide continuous improvement initiatives, and ensure that quality is fully integrated into business and operational decision-making.
Key Responsibilities
Lead and oversee the implementation, maintenance, and performance of the Quality Management System (QMS) in compliance with ISO 9001
Manage and develop QA/QC teams of approximately eight professionals at the Bangalore site
Serve as a core member of the site leadership team, integrating quality strategy into operational goals
Interpret regulatory and compliance requirements and translate them into actionable quality processes
Implement and sustain closed-loop CAPA systems, including trending and effectiveness monitoring
Conduct regular QMS audits and assessments to ensure regulatory compliance and identify improvement opportunities
Review manufacturing processes, validation protocols, and reports to ensure alignment with regulatory expectations
Provide clear and effective communication on quality and compliance matters across cross-functional teams
Drive continuous improvement through process optimization, risk management, and training initiatives
Foster a culture aligned with Thermo Fisher Scientific values of Integrity, Intensity, Innovation, and Involvement
Required Qualifications and Experience
Advanced degree with a minimum of 6 years of experience, or Bachelor’s degree with a minimum of 8 years of experience in a GMP or regulated industry
At least 3 years of proven leadership experience managing quality assurance or quality control teams
Educational background in Chemistry, Biology, Engineering, Pharmacy, or a related scientific discipline
Strong working knowledge of GMP regulations, ISO standards, and global quality systems
Preferred Qualifications
Professional certifications such as ASQ, Six Sigma, Lean, or equivalent
Hands-on experience with document control systems and electronic quality management systems (eQMS)
Familiarity with risk management tools and continuous improvement methodologies
Core Competencies and Skills
In-depth expertise in quality systems including document control, change management, deviations, CAPA, and validation
Strong analytical, problem-solving, and data-driven decision-making abilities
Excellent project management and cross-functional leadership skills
High-impact written and verbal communication, including technical documentation
Ability to influence stakeholders and build a sustainable quality culture across the organization
Strong interpersonal, negotiation, and conflict resolution skills
Comfort working in complex, regulated environments with evolving requirements
Candidate Profile
The ideal candidate is a proactive and self-driven quality leader with a strong sense of ownership and accountability. The successful Quality Manager will demonstrate the ability to learn and apply new regulatory concepts, mentor teams, and collaborate effectively with cross-functional partners while maintaining the highest standards of quality and compliance.
Compensation, Benefits, and Equal Opportunity
Thermo Fisher Scientific offers competitive compensation, annual performance incentives, comprehensive healthcare coverage, and a broad range of employee benefits. Employees benefit from long-term career development opportunities within an innovative and globally recognized organization.
Thermo Fisher Scientific is an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.
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