Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
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:
- Lead a Quality Control team responsible for ensuring product excellence and regulatory compliance at Thermo Fisher Scientific
- Oversee outsourced testing operations, including raw materials testing and related events
- Be responsible for the on-time CoA release
- Lead and contribute to the on-time material release
- Lead the on-time maintenance, qualification, and calibration within the QC department
- Support data integrity and Good Manufacturing Practices (GMP) while developing team members through mentoring and training
- Ensure laboratory readiness for regulatory inspections and customer audits while improving operational efficiency through quality metrics and process improvements
- Support analytical testing, method validation, and quality systems while fostering a culture of continuous improvement
Requirements:
- Advanced degree plus 6 years of experience, or Bachelor's degree plus 8 years of experience in regulated pharmaceutical/biotech industry quality control
- Preferred Fields of Study: Chemistry, Biology, Biochemistry, Pharmaceutical Sciences
- 5+ years of people management experience leading QC laboratory teams
- Extensive knowledge of cGMP regulations, quality systems, and regulatory requirements (FDA, EMA, ICH)
- Strong understanding of analytical testing methods and laboratory operations
- Strong experience managing laboratory investigations, deviations, and CAPA processes
- Demonstrated success implementing and improving quality systems and processes
- Experience with laboratory information management systems (LIMS) and data integrity requirements
- Leadership experience developing and mentoring staff
- Project management and organizational skills
- Clear written and verbal communication skills
- Experience supporting regulatory inspections and customer audits
- Proficiency with standard business software (MS Office) and quality systems
- Ability to adapt to changing priorities
- Problem-solving skills and scientific decision-making abilities