Thermo Fisher Scientific

Site Quality Head, Quality Director

Thermo Fisher Scientific • $135K — $160K *
High Point, NC 27265In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's or advanced degree in Life Sciences, Engineering, Pharmaceutical Sciences, or related field
  • 12 to 15 years of pharmaceutical manufacturing experience, with significant leadership roles in quality
  • Strong knowledge of OSD manufacturing processes and cGMP requirements
  • Comprehensive understanding of FDA, EMA, and global regulatory requirements
  • Proven record in managing and developing quality teams
  • Expertise in quality systems management including CAPA and document control
  • Strong communication and collaboration skills across all levels

Responsibilities

  • Establish and implement a site quality strategy aligning with business objectives
  • Represent Quality on the Site Leadership Team, embedding quality principles into decision making
  • Promote a proactive quality culture focused on risk management and continuous improvement
  • Ensure compliance with global regulatory standards and lead regulatory inspections
  • Provide quality oversight for manufacturing processes including granulation and compression
  • Lead and develop the site Pharmaceutical Quality System and quality organization
  • Monitor and improve key performance metrics related to quality and compliance

Benefits

  • Collaborative office environment
  • Opportunity to lead quality initiatives at a prominent CDMO
  • Professional growth opportunities within a global organization
  • Engagement with regulatory authorities and impact on site operations
  • Travel opportunities for international regulatory interactions
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

DESCRIPTION:

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

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

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