Site Quality Leader, Global Compliance & Release

ThermoFisher Scientific; High Point (NC); On-site; USD 180,000 - 280,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Site Quality Head for our Oral Solid Dose CDMO facility in North Carolina. You will lead QA initiatives, ensure regulatory compliance, and drive continuous improvement across manufacturing operations, collaborating with cross-functional teams to protect product quality and support our mission.

You will hold final authority for batch disposition, oversee the Pharmaceutical Quality System, and represent Quality on the Site Leadership Team.

Qualifications

• Bachelor's or advanced degree in Life Sciences, Engineering, Pharmaceutical Sciences, or related field.
• 12 to 15 years of pharmaceutical manufacturing experience including significant leadership roles in quality.
• Strong knowledge of OSD manufacturing processes, cGMP requirements, and regulatory expectations.
• Proven experience leading and developing quality teams in a pharmaceutical manufacturing environment.
• Expertise in managing quality systems including CAPA, change control, deviations, complaints, and document control.
• Strong understanding of risk management methodologies and quality tools.
• Experience managing regulatory inspections, customer audits, and serving as primary quality interface with authorities.
• Proficiency in root cause analysis and implementation of corrective actions.
• Experience with validation, qualification, and computer system compliance.
• Strong written and verbal communication skills.
• Travel up to 20% may be required.
• Experience implementing continuous improvement initiatives in a pharmaceutical manufacturing setting.
• Multilingual abilities highly valued for international sites.

Responsibilities

• Establish and implement a site quality strategy aligned with business objectives and regulatory expectations.
• Represent Quality on the Site Leadership Team and embed quality principles into site decision making.
• Promote a proactive quality culture focused on risk management, compliance, and continuous improvement.
• Ensure full compliance with global regulatory standards including FDA 21 CFR Parts 210 and 211, EU GMP, and ICH guidelines.
• Maintain continuous inspection readiness and lead regulatory inspections.
• Provide quality oversight for OSD manufacturing processes.
• Lead the site Pharmaceutical Quality System.
• Hold final authority for batch disposition and product release decisions.
• Serve as the senior quality interface for CDMO clients.
• Lead and develop the site quality organization.
• Monitor and improve key performance metrics including regulatory inspection outcomes, batch quality performance, deviation and CAPA cycle times, and supplier quality performance

Skills

Leadership

Regulatory compliance

Quality systems

Risk management

Data integrity

Communication skills

Education

Bachelor's or advanced degree in Life Sciences/Engineering/Pharmaceutical Sciences

Job description

Thermo Fisher Scientific is seeking a Site Quality Head for our Oral Solid Dose CDMO facility in North Carolina. You will lead QA initiatives, ensure regulatory compliance, and drive continuous improvement across manufacturing operations, collaborating with cross-functional teams to protect product quality and support our mission.

You will hold final authority for batch disposition, oversee the Pharmaceutical Quality System, and represent Quality on the Site Leadership Team.