Site Quality Head, Quality Director

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

DESCRIPTION:  

At  Thermo  Fisher Scientific,  you'll  lead Quality Assurance initiatives that make a meaningful impact on global health. As the Site Quality Head for our Oral Solid Dose CDMO facility,  you'll  ensure regulatory compliance, drive continuous improvement, and uphold the highest quality standards across manufacturing operations. Working collaboratively with cross-functional teams,  you'll  provide strategic direction for quality systems while fostering a culture of excellence.  You'll  apply your  expertise  to protect product quality, enhance customer satisfaction, and enable our mission of making the world healthier,  cleaner  and 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 and  Thermo  Fisher 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 of  high quality  products including tablets, capsules, granules, and soft gel formulations.  

How you will make an impact:  

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  

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 is  identified  

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  

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  

Expertise  in 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 be  required  

Experience implementing continuous improvement initiatives in a pharmaceutical manufacturing setting  

Multilingual abilities highly valued for international sites