Associate Manager, Quality Assurance

Job description

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.