Site Quality Head, Quality Director
Thermo Fisher Scientific
Site Quality Head, Quality Director
Job Description
Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionDESCRIPTION: 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
Locations
- USA, North Carolina, High Point
Required Qualifications
- Experience implementing continuous improvement initiatives in a pharmaceutical manufacturing setting (experience)
- Experience implementing continuous improvement initiatives in a pharmaceutical manufacturing setting (experience)
- Multilingual abilities highly valued for international sites (experience)
- Multilingual abilities highly valued for international sites (experience)
Responsibilities
- Establish and implement a site quality strategy aligned with business objectives and regulatory expectations
- 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
- 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
- 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
- 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
- Maintain continuous inspection readiness and lead regulatory inspections
- Provide quality oversight for OSD manufacturing processes
- Provide quality oversight for OSD manufacturing processes
- Lead the site Pharmaceutical Quality System
- Lead the site Pharmaceutical Quality System
- Hold final authority for batch disposition and product release decisions
- Hold final authority for batch disposition and product release decisions
- Serve as the senior quality interface for CDMO clients
- Serve as the senior quality interface for CDMO clients
- Lead and develop the site quality organization
- Lead and develop the site quality organization
- Serve as the primary quality interface with regulatory authorities
- Serve as the primary quality interface with regulatory authorities
- Oversee granulation, compression, and coating processes
- Oversee granulation, compression, and coating processes
- Manage blend uniformity and content uniformity controls
- Manage blend uniformity and content uniformity controls
- Supervise dissolution testing and stability programs
- Supervise dissolution testing and stability programs
- Direct cleaning validation and process validation lifecycle
- Direct cleaning validation and process validation lifecycle
- Implement risk-based decision making aligned with ICH Q9 and ICH Q10 quality management principles
- 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
- Ensure strong data integrity governance aligned with ALCOA plus principles
- Exercise authority to halt manufacturing when quality or compliance risk is identified
- Exercise authority to halt manufacturing when quality or compliance risk is identified
- Support client audits and collaborate with operations and development teams
- Support client audits and collaborate with operations and development teams
- Build high performing teams and succession pipelines within the quality organization
- 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
- Monitor and improve key performance metrics including regulatory inspection outcomes, batch quality performance, deviation and CAPA cycle times, and supplier quality performance
- Bachelor's or advanced degree in Life Sciences, Engineering, Pharmaceutical Sciences, or related field
- 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
- 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
- Strong knowledge of OSD manufacturing processes, cGMP requirements, and regulatory expectations
- Comprehensive understanding of FDA, EMA, and global regulatory requirements
- Comprehensive understanding of FDA, EMA, and global regulatory requirements
- Proven experience leading and developing quality teams in a pharmaceutical manufacturing environment
- 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
- Expertise in managing quality systems including CAPA, change control, deviations, complaints, and document control
- Strong understanding of risk management methodologies and quality tools
- Strong understanding of risk management methodologies and quality tools
- Experience managing regulatory inspections, customer audits, and serving as primary quality interface with authorities
- Experience managing regulatory inspections, customer audits, and serving as primary quality interface with authorities
- Proficiency in root cause analysis and implementation of corrective actions
- Proficiency in root cause analysis and implementation of corrective actions
- Expertise in validation, qualification, and computer system compliance
- Expertise in validation, qualification, and computer system compliance
- Strong written and verbal communication skills
- Strong written and verbal communication skills
- Ability to collaborate effectively across all organizational levels and with CDMO clients
- Ability to collaborate effectively across all organizational levels and with CDMO clients
- Experience with quality management software systems
- Experience with quality management software systems
- Strong project management and problem-solving capabilities
- Strong project management and problem-solving capabilities
- Travel up to 20% may be required
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