Thermo Fisher Scientific

Senior Quality Project Lead - Customer Quality

Thermo Fisher Scientific • $90K — $120K *
Greenville, NC 27858In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a relevant scientific or technical field
  • 5+ years in Quality Assurance or related pharmaceutical manufacturing
  • Experience in sterile manufacturing operations preferred
  • Experience with customer manufacturing projects or cross-functional initiatives
  • Familiarity with ISO 13485 and medical device quality systems is a plus

Responsibilities

  • Lead Quality efforts for customer manufacturing programs in sterile settings
  • Ensure compliance through oversight of manufacturing, packaging, and quality activities
  • Review and authorize quality documents and deviations
  • Make decisions on batch disposition based on quality assessments
  • Collaborate with cross-functional teams for new product introductions
  • Support compliance assessments and continuous improvement initiatives
  • Maintain Quality Systems for regulatory inspection readiness

Benefits

  • Work in a standard Mon-Fri schedule
  • Office-based environment
  • Opportunity to influence quality and compliance culture
  • Engage directly with customers and cross-functional teams
  • Support for professional development and certifications
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

As the Senior Quality Project Lead - Customer Quality, you will serve as the primary Quality partner supporting customer manufacturing programs within a sterile manufacturing environment. You'll provide technical Quality leadership throughout the manufacturing lifecycle, ensuring products, processes, and documentation comply with current Good Manufacturing Practice (cGMP) regulations, customer requirements, and applicable quality standards.

This role is ideal for someone who enjoys balancing quality, compliance, manufacturing execution, and customer expectations while making independent decisions that protect product quality and support on-time delivery.

A Day in the Life
  • Serve as the Quality Project Lead for assigned customer manufacturing programs within a sterile manufacturing environment.
  • Provide Quality oversight for manufacturing, packaging, investigations, batch record review, and customer-related quality activities.
  • Review and approve deviations, change controls, procedures, training documentation, and quality records while ensuring compliance with applicable regulatory requirements.
  • Perform Quality batch disposition and make release decisions based on product quality, compliance, and risk assessments.
  • Partner with Manufacturing, Engineering, Validation, Regulatory Affairs, and customers to support new product introductions and ongoing commercial manufacturing.
  • Interpret and apply current pharmaceutical regulations and quality standards to support compliant manufacturing operations.
  • Lead or support compliance assessments, continuous improvement initiatives, and implementation of evolving regulatory requirements.
  • Evaluate product, compliance, and business risks while making sound Quality decisions.
  • Act as a technical Quality resource during customer projects, manufacturing investigations, and process improvements.
  • Support implementation and maintenance of Quality Systems that ensure inspection readiness and regulatory compliance.
  • Champion a culture of Quality, continuous improvement, and customer focus.

Keys to Success
Education
  • Bachelor's degree in Engineering, Life Sciences, Chemistry, Microbiology, Pharmacy, or another scientific or technical discipline required.

Experience
  • 5+ years of Quality Assurance, Manufacturing Quality, Operations, or related pharmaceutical manufacturing experience.
  • Experience supporting sterile manufacturing operations is strongly preferred.
  • Experience serving as a Quality representative supporting customer manufacturing projects or cross-functional initiatives.
  • Experience making Quality decisions involving deviations, change controls, investigations, and batch disposition.
  • Experience within a Contract Manufacturing Organization (CMO) environment is preferred.
  • Experience supporting products with medical device attributes and familiarity with ISO 13485 quality systems is strongly preferred.

Knowledge, Skills & Abilities
  • Strong working knowledge of cGMP regulations and pharmaceutical Quality Systems.
  • Knowledge of ISO 13485 quality management systems and medical device quality requirements preferred.
  • Understanding of sterile manufacturing operations and associated quality risks.
  • Proven ability to independently assess compliance risk and make sound Quality decisions.
  • Experience reviewing and approving deviations, investigations, change controls, procedures, and batch documentation.
  • Strong project leadership and organizational skills with the ability to manage multiple priorities in a fast-paced manufacturing environment.
  • Excellent written and verbal communication skills with the ability to collaborate across technical and operational teams.
  • Strong interpersonal, negotiation, and influencing skills with the confidence to provide independent Quality oversight.
  • Experience supporting new product introductions and implementation of new regulatory requirements.
  • Demonstrated attention to detail with strong technical writing and documentation skills.
  • Professional certifications such as Certified Quality Auditor (CQA), ASQ certifications, or Six Sigma training are a plus.

Competencies
  • Customer Focus
  • Integrity
  • Accountability
  • Decision Quality
  • Collaboration
  • Continuous Improvement
  • Technical Learning
  • Quality Mindset
  • Effective Communication
  • Problem Solving

If you're passionate about Quality, enjoy partnering directly with customers and cross-functional teams, and want to help shape the future of sterile pharmaceutical manufacturing, we'd love to hear from you.

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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