Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

DESCRIPTION:
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.
 

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.Strong understanding of quality systems including document control, change control, deviations, CAPA, and validationDemonstrated success leading quality operations and developing quality assurance staffStrong 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

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.

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 rolePreferred Fields of Study: Chemistry, Biology, Engineering, Pharmacy or relatedAdditional certifications (ASQ, Six Sigma, etc.) desirable

Travel Requirements: None.
 

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.

About You

The successful candidate will be self-motivated and a self-starter who is excellent at learning and applying new concepts for process or product improvements, possess excellent oral and written communication skills to connect to peers and leadership, and will be an excellent teammate with the ability to work with different colleagues.

Equal Opportunity Statement & Benefits

ThermoFisher 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 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.