Site Quality Head, Quality Director

Regulatory Toolkit; High Point (NC); On-site; USD 180,000 - 260,000; Full time

Job summary

Thermo Fisher Scientific seeks a Site Quality Head for our Oral Solid Dose CDMO facility. You will lead QA initiatives, ensure regulatory compliance, and drive continuous improvement across manufacturing operations, enabling high-quality products and patient safety.

As the independent Quality authority on the Site Leadership Team, you will oversee the Pharmaceutical Quality System, batch disposition, and regulatory inspections, shaping a culture of excellence and client partnership.

Qualifications

• Bachelor's or advanced degree in Life Sciences, Engineering, Pharmaceutical Sciences, or related field.
• 12–15 years of pharmaceutical manufacturing experience with leadership in quality.
• Strong knowledge of OSD manufacturing, cGMP, and regulatory expectations.
• Experience leading regulatory inspections and client audits.

Responsibilities

• Lead quality strategy and regulatory compliance for an Oral Solid Dose CDMO facility.
• Own site Pharmaceutical Quality System and release decisions.
• Represent Quality on the Site Leadership Team and drive continuous improvement.
• Halt manufacturing when quality or compliance risk is identified and support client audits.

Skills

QA leadership

cGMP knowledge

FDA/EMA regulatory

OSD manufacturing

CAPA, change control

risk management

data integrity (ALCOA+)

cross-functional collaboration

Education

Bachelor's or higher in Life Sciences/Engineering/Pharmaceutical Sciences

Tools

Quality Management Software

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

AtThermoFisher Scientific,you'lllead Quality Assurance initiatives that make a meaningful impact on global health. As the Site Quality Head for our Oral Solid Dose CDMO facility,you'llensure regulatory compliance, drive continuous improvement, and uphold the highest quality standards across manufacturing operations. Working collaboratively with cross-functional teams,you'llprovide strategic direction for quality systems while fostering a culture of excellence.You'llapply yourexpertiseto protect product quality, enhance customer satisfaction, and enable our mission of making the world healthier,cleanerand safer.

The Site Quality Head serves as the independent Quality authority on the Site Leadership Team and holds ultimate responsibility for ensuring that all products manufactured, tested, and released from the site meet global regulatory requirements andThermoFisher Scientific quality standards. This role is critical in leading and owning the quality strategy, regulatory compliance, and Pharmaceutical Quality System execution for an Oral Solid Dose CDMO manufacturing facility, ensuring consistent delivery ofhigh qualityproducts including tablets, capsules, granules, and soft gel formulations.

How you will make an impact:

• Establish and implement a site quality strategy aligned with businessobjectivesand 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

What you will do:

• Serve as the primary quality interface with regulatory authorities
• Oversee granulation, compression, and coating processes
• Manage blend uniformity and content uniformity controls
• Supervise dissolution testing and stability programs
• Direct cleaning validation and process validation lifecycle
• Implement risk-based decision making aligned with ICH Q9 and ICH Q10 quality management principles
• Ensure strong data integrity governance aligned with ALCOA plus principles
• Exercise authority to halt manufacturing when quality or compliance risk isidentified
• Support client audits and collaborate with operations and development teams
• Build high performing teams and succession pipelines within the quality organization
• Monitor and improve key performance metrics including regulatory inspection outcomes, batch quality performance, deviation and CAPA cycle times, and supplier quality performance

REQUIREMENTS:

How you will get here:

• 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
• Comprehensive understanding of FDA, EMA, and global regulatory requirements
• Proven experience leading and developing quality teams in a pharmaceutical manufacturing environment
• Expertisein 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
• Proficiencyin root cause analysis and implementation of corrective actions
• Expertisein validation, qualification, and computer system compliance
• Strong written and verbal communication skills
• Ability to collaborate effectively across all organizational levels and with CDMO clients
• Experience with quality management software systems
• Strong project management and problem-solving capabilities
• Travel up to 20% may berequired
• Experience implementing continuous improvement initiatives in a pharmaceutical manufacturing setting
• Multilingual abilities highly valued for international sites