Softgel Jobs (NOW HIRING)

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Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day by enabling our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping take science a step beyond through innovative solutions that address some of the world's toughest challenges.

Join the Drug Product Division (DPD), part of Thermo Fisher Scientific's Pharma Services Group (PSG), where we partner with leading pharmaceutical and biotechnology companies to manufacture life-changing medicines. As a global Contract Manufacturing Organization (CMO), we provide the scientific, manufacturing, and quality expertise our customers depend on to bring sterile injectable, oral solid dose, softgel, and combination products safely to patients worldwide.

Our Greenville, North Carolina site continues to expand its capabilities, including supporting new sterile products with medical device attributes. This creates an exciting opportunity for experienced Quality professionals who enjoy working at the intersection of pharmaceutical manufacturing, customer partnership, and regulatory compliance.

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.

• 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.

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

• 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.

• 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.

• Customer Focus

• Integrity

• Accountability

• Decision Quality

• Collaboration

• Continuous Improvement

• Technical Learning

• Quality Mindset

• Effective Communication

• Problem Solving

At Thermo Fisher Scientific, you'll have the opportunity to help customers manufacture therapies that improve lives around the world while working on innovative sterile manufacturing programs, including products with medical device attributes. You'll collaborate with talented colleagues across Quality, Manufacturing, Engineering, and Customer teams in an environment that values technical excellence, continuous improvement, and career growth.

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.