Job Description

Work Schedule Standard (Mon-Fri)Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degrees, Office, Will work with hazardous/toxic materialsSite Quality LeadThermo Fisher Scientific Inc. is looking for a motivated and experienced professional to join our team in Ahmedabad as a Site Quality Lead. In this role, you will be responsible for ensuring that clinical supplies are stored and distributed in compliance with Fisher Clinical Services approved procedures and policies, as well as industry regulations such as cGMP, cGDP. This position offers a chance to contribute to high-quality systems and work closely with both internal and external partners on quality-related issues.Job Responsibilities:

• Ensure compliance with internal standards, local, and international quality and regulatory guidelines for clinical trials supply chain activities
• Deliver monthly reporting on key performance indicators and provide insights on trends, risks, and mitigation plans
• Provide guidance and advice on regulatory and quality matters to clients, suppliers, and internal associates
• Handle internal and external audits and follow-up on resulting observations and opportunities for improvement
• Mentor and develop the Quality team to deliver outstanding results
• Partner and collaborate to find opportunities and solutions related to regulatory and quality matters impacting the business
• Lead management reviews of process performance, product quality, and the Pharmaceutical Quality System, advocating for continual improvement
• Establish effective communication processes to ensure timely reporting of quality issues to the appropriate levels of management.
• Take a leadership role in service and quality improvement initiatives

Job Requirements:

• Bachelors degree or equivalent experience in life science/medical/pharmacy/quality assurance/regulatory affairs or related field
• 5+ years of strong QA and production experience or experience in GMP/QMS settings in quality assurance and regulatory affairs
• Knowledge of IMP process, including handling complex protocols and key clients
• Ability to handle complex problems/projects with independent decision-making and analytical thinking skills
• Flexible, adaptable, and strong customer management skills
• Ability to work independently under pressure and handle multiple tasks
• Strong leadership and influencing skills
• Good organizational, written, and verbal communication skills in English

Thermo Fisher Scientific Inc. is an equal opportunity employer (EOE) and values diversity in our workforce. We are committed to providing equal opportunities to all individuals regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We also provide reasonable accommodations to individuals with disabilities in the job application process. If you need assistance or an accommodation due to a disability, please contact us at 1-855-471-2255.

Thermo Fisher Scientific