Leading a Quality Control team that supports pharmaceutical manufacturing is the core of this supervisory role. The supervisor ensures that all laboratory activities meet cGMP standards, regulatory requirements, and customer expectations. This position provides technical and operational leadership across testing activities, from raw materials to finished products, while managing the complexity of multiple analytical methods, customer requirements, and challenging priorities and timelines.
Responsibilities
Lead, coach, and develop the QC team, setting clear expectations and aligning day-to-day activities with site and company objectives
Plan and coordinate laboratory operations, balancing workload, resources, testing requirements, customer priorities, and turnaround times
Provide technical oversight for analytical testing and troubleshooting involving methods and instrumentation such as HPLC and GC testing
Proactively identify risks, bottlenecks, and emerging issues that could affect quality, compliance, customer commitments, or timelines; lead appropriate problem-solving and escalation
Participate actively in customer calls, communicate laboratory performance and technical matters clearly, and help resolve customer concerns
Support and participate in customer audits and regulatory inspections, including preparation, responses, and follow-up actions
Take an active role in laboratory investigations, including assessment of results, root cause analysis, definition of corrective and preventive actions, and follow-through to closure
Review and interpret operational, quality, and service metrics and KPIs; use trends to anticipate issues, set priorities, and drive timely improvements
Ensure accurate, complete, and compliant laboratory documentation, with strong attention to data integrity and recordkeeping requirements
Maintain and improve SOPs, workflows, and laboratory processes; promote continuous improvement and effective risk management
Partner with other functions to support manufacturing operations and deliver reliable results to customers
Adjust schedules as needed to meet operational requirements
Requirements
Advanced degree and at least 3 years of relevant experience, or a bachelor’s degree and at least 5 years of relevant experience, in pharmaceutical or biotechnology Quality Control
At least 2 years of experience in a team leadership or supervisory role
Degree in Chemistry, Biology, Biochemistry, Microbiology, or a related scientific field
Strong knowledge of cGMP, FDA regulations, ICH guidelines, quality systems, and data integrity principles
Experience with analytical testing methods and laboratory instrumentation, such as HPLC, GC, and dissolution testing
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Demonstrated ability to lead and develop teams, set priorities, and maintain engagement in a demanding operational environment
Experience managing laboratory operations, including workload planning, scheduling, resource allocation, and process improvement
Proven ability to manage competing customer requirements and challenging timelines while maintaining quality and compliance
Strong investigation, troubleshooting, root cause analysis, and risk assessment skills
Experience supporting customer audits, regulatory inspections, and related follow-up activities
Excellent technical writing skills, including preparation and review of SOPs, investigations, and regulatory documentation
Proficiency with LIMS, quality management systems, and Microsoft Office applications
Strong communication and interpersonal skills, with the ability to engage effectively with customers and stakeholders at all levels
Excellent organizational and project management skills
Nice to have:
Additional certifications in quality systems, regulatory compliance, or project management
Important Details
Schedule: Standard office hours (40 hours per week)
About the Company
Thermo Fisher Scientific enables its customers to make the world healthier, cleaner, and safer. The company provides 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 food is safe, or helping find cures for cancer.
