Associate Manager, Quality Assurance

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Join Us as an Associate Manager Quality Assurance - Make an Impact at the Forefront of Innovation
The Associate Manager Quality Assurance has responsibility for a QA team implementing elements of the quality management system. The role involves ensuring internal and/or client processes, systems and/or projects are compliant and inspection ready. The Clinical Quality Assurance Supervisor manages and develops staff and ensures delivery of quality solutions in a collaborative cross-functional environment.

What You'll Do:
• Manage the day-to-day operations of a QA team and provide oversight, development and performance management to staff to meet performance objectives
• Assess with supervisors priority of projects and monitor work assignments ensuring adequate resourcing to meet internal and client timelines and provide quality deliverables
• Assist senior management in the evaluation of QA programs to help maintain regulatory compliance and efficiency of QA audits
• Evaluate issues and trends reported by QA staff and determine appropriate departmental interpretation. Identify issues that may require follow-up or improvement. Communicate findings to staff and senior management
• Participate in client and regulatory inspections in order to provide information regarding the QA program and facilitate responses


Education & Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years).
• 1+ year of leadership responsibility
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.


Knowledge, Skills, Abilities:
• Solid leadership and time management skills
• Knowledge of appropriate regulations and applicable global pharmaceutical industry guidelines

Knowlege of Nonconformance, Investigations, Root Cause Analysis and CAPA.
• For Lab QA Management, knowledge of analytical methodologies, instrumentation and method validation required
• Good verbal and written communication skills
• Demonstrated proficiency with regulations and guideline interpretation, proper documentation and QA departmental policies and procedures
• Detail oriented with ability to deal with multiple and changing priorities

Working Conditions and Environment:
• Work is performed in an office and/or a laboratory and/or a clinical environment with exposure to electrical equipment.
• Exposure to biological fluids with potential exposure to infectious organisms. Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.