Quality Control Manager

Work Schedule

Environmental Conditions

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.

Division/Site Specific Information

Position is based High Point, North Carolina. Position will support our Drug Product Division (DPD) at Thermo Fisher Scientific. 

A Day in the Life

• Oversee testing operations including raw materials, in-process controls, environmental monitoring, and finished product release.
• 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.

Keys to Success:

Education:

• BS Degree required. Preferred Fields of Study: Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field.
• Advanced degree preferred.

Experience:

•     Advanced degree plus 6 years of experience, or Bachelor’s degree plus 8 years of experience in regulated pharmaceutical or biotech industry quality control.

•     5+ years of people management experience leading QC laboratory teams.

•     Experience managing laboratory investigations, deviations, and CAPA processes.

•     Experience with laboratory information management systems (LIMS) and data integrity requirements.

•     Experience supporting regulatory inspections and customer audits.

Knowledge, Skills, Abilities:

•     Extensive knowledge of cGMP regulations, quality systems, and regulatory requirements, including FDA, EMA, and ICH.

•     Strong understanding of analytical testing methods and laboratory operations.

•     Demonstrated success implementing and improving quality systems and processes.

•     Leadership experience developing and mentoring staff.

• Effective project management and organizational skills.

•     Clear written and verbal communication skills.

•     Proficiency with standard business software, including MS Office, and quality systems.

•     Ability to adapt to changing priorities.

•     Sound problem-solving skills and scientific decision-making abilities.

•     Commitment to workplace safety and compliance.

•     Effective client communication skills.