QC Laboratory Manager/Quality Engineer

About the role

Thermo Fisher Scientific is seeking a Manager, QC Laboratory & Quality Engineer to join their Quality Assurance team. This unique dual-role opportunity combines leadership of their Quality Control Laboratory with site-level Quality Engineering responsibilities.

Key Responsibilities

• Lead daily operations of the QC Laboratory, including supervision, development, and performance management of laboratory personnel.
• Ensure laboratory activities are conducted in compliance with applicable cGMP, ISO, regulatory, and company requirements.
• Drive site quality engineering initiatives focused on risk reduction, process improvement, and quality system effectiveness.
• Support and lead investigations, deviations, nonconformances, CAPAs, and root cause analyses.
• Partner with cross-functional teams to improve manufacturing processes, product quality, and operational performance.
• Support validation activities and quality risk management programs.
• Participate in internal audits, customer audits, and regulatory inspections.
• Promote a culture of quality, compliance, accountability, and continuous improvement throughout the organization.
• Develop and deliver quality-related training and guidance to site personnel.

Required Qualifications

• Bachelor's degree in Biology, Chemistry, Engineering, or a related scientific discipline.
• Minimum of 5 years of quality experience in a regulated manufacturing environment (pharmaceutical, medical device, biotechnology, or related industry).
• Minimum of 2 years of supervisory or team leadership experience.
• Strong knowledge of cGMP regulations, quality systems, and applicable ISO standards.
• Experience applying quality risk management principles and tools.
• Demonstrated ability to lead initiatives, solve complex problems, and influence cross-functional teams.

Preferred Qualifications

• ASQ certifications such as CQE, CQA, or equivalent.
• Experience with batch record review, deviation management, CAPA, and change control systems.
• Experience implementing quality improvements and continuous improvement initiatives.
• Knowledge of validation principles and quality engineering methodologies.
• Experience hosting regulatory inspections and customer audits.
• Familiarity with electronic quality management systems such as TrackWise and SAP.
• Strong project management, organizational, and communication skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.