Quality Assurance Manager

Work Schedule & Environment

Standard (Mon-Fri)
Office

About the Role

Join us as a Quality Assurance Manager and contribute to making the world healthier, cleaner and safer. You'll lead quality operations in a GMP environment, ensuring compliance with regulatory requirements while driving continuous improvement. Working with cross-functional teams, you'll provide quality oversight for manufacturing operations, laboratory activities, and quality systems. Your guidance will be instrumental in fostering a culture of quality excellence and developing teams dedicated to delivering exceptional results for our customers.

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Key Responsibilities

• Oversee the deployment and performance of the Quality Management System (ISO 9001)
• Lead and manage QA/QC teams (approx. 8 professionals) at Bangalore
• Serve on the site Leadership Team and ensure Quality is integrated into all operations strategies
• Review, analyze, and translate regulatory requirements into actionable deliverables
• Implement and maintain closed-loop CAPA processes to monitor and trend product/system performance and corrective actions
• Conduct periodic QMS assessments for regulatory compliance and recommend improvement strategies
• Review manufacturing processes, validation plans, and reports for regulatory alignment
• Communicate quality and compliance matters effectively across departments
• Make necessary process and training adjustments for sustained compliance and high standards
• Demonstrate strong critical thinking in complex quality scenarios
• Adhere to 4-I values: Integrity, Intensity, Innovation, and Involvement
• Perform other duties as assigned

Keys to Success

• Manage both research and regulated Quality System requirements through every stage of product life cycle
• Guide teams to adhere to company standards and applicable regulations
• Influence continuous adoption of quality assurance best practices at every organizational level
• Represent the quality system internally and externally, requiring excellent communication, attention to detail, and a sense of urgency

Required Qualifications

• Advanced Degree plus 6 years of experience, or bachelor's degree plus 8 years of experience in GMP/regulated environment, including 3+ years in leadership role
• Strong understanding of quality systems including document control, change control, deviations, CAPA, and validation
• Demonstrated success leading quality operations and developing quality assurance staff
• Strong project management and cross-functional leadership abilities
• Excellent analytical and problem-solving skills with data-driven decision making
• Strong written and verbal communication skills, including technical writing
• Demonstrated ability to guide and foster quality culture across organizations
• Proficiency with quality systems software (document management systems)
• Knowledge of risk management tools and continuous improvement methodologies

Preferred Qualifications

• Preferred Fields of Study: Chemistry, Biology, Engineering, Pharmacy or related
• Additional certifications (ASQ, Six Sigma, etc.) desirable

Skills & Abilities

• Strategic mindset and goal orientation
• Ability to persuade, negotiate, and gain commitment from stakeholders
• Ownership of actions and effective project/people management
• High standards for quality/compliance
• Strong relationship-building and conflict resolution abilities
• Credible communicator, both oral and written
• Comfortable with ambiguity and mentoring others
• Self-motivated and a self-starter who is excellent at learning and applying new concepts for process or product improvements
• Excellent teammate with the ability to work with different colleagues

Travel Requirements

None

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Benefits

We offer competitive pay, annual incentives, healthcare, diverse benefits, and abundant opportunities for career development in an innovative and energetic environment. Our culture stands for integrity, intensity, involvement, and innovation.

Equal Opportunity Statement

Thermo Fisher Scientific is an equal opportunity employer, committed to diversity and inclusion. All qualified applicants will receive consideration without discrimination based on any protected status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.