Sr. Director, Quality - Site Quality Head; Greenville, NC)

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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 single day to enable 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 to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

At Thermo Fisher Scientific, you’ll lead and own the site quality strategy, sterility assurance framework, and Pharmaceutical Quality System (PQS) execution for a multi-platform CDMO manufacturing site producing both sterile and Oral Solid Dose (OSD) products. As the Site Quality Head, you’ll be the independent Quality authority on the Site Leadership Team and hold ultimate responsibility for ensuring that all products manufactured, tested, and released from the site meet global regulatory requirements and Thermo Fisher Scientific quality standards.

The role requires strong leadership capability across both aseptic/sterile manufacturing and OSD operations, ensuring patient safety, product quality, regulatory compliance, inspection readiness, and reliable delivery across platforms including aseptically manufactured injectables and devices, and OSD products such as tablets, capsules and granules.

Establish and implement an integrated site quality strategy aligned with business objectives, global regulatory expectations, and Thermo Fisher Scientific quality standards across both Sterile and OSD operations. Represent Quality as a core member of the Site Leadership Team and ensure quality and patient-safety considerations are embedded in strategic and operational decision making. Promote a proactive, patient-first quality culture focused on compliance, risk management, operational excellence, and continuous improvement.

Ensure the effectiveness of the site Pharmaceutical Quality System and drive risk-based decision making across all manufacturing platforms. Define and govern the site sterility assurance framework, including the contamination control strategy (CCS), and ensure compliance with EU GMP Annex1 requirements for aseptic process integrity. Provide Quality oversight for OSD manufacturing processes and associated critical quality controls, including granulation, compression, coating, blend/content uniformity, dissolution, stability, and cleaning validation.

Ensure full compliance with applicable global regulatory requirements, including FDA
21CF
RParts
210and
211, EUGMP, ICH guidelines, and other relevant global standards, while maintaining continuous inspection readiness. Hold final Quality authority for batch disposition and product release decisions across both Sterile and OSD products. Serve as the senior Quality interface for regulatory authorities and CDMO customers, including customer audits, regulatory submissions, inspections, commitments, and remediation activities. Lead and develop the site Quality organization, building high-performing teams, strong succession pipelines, and capability to support both sterile and OSD manufacturing excellence.

Lead the site Quality function and provide clear governance, priorities, resources, and decision-making standards across Sterile and OSD Quality teams. Lead regulatory inspections, including FDA, EMA, and all applicable, and own site responses to observations, commitments, remediation programs, and regulatory follow-up. Provide governance for sterility assurance programs including environmental monitoring, cleanroom management, aseptic process simulations/media fills, operator qualification, contamination control, and aseptic process validation.

Provide appropriate Quality governance and approval of validation strategies, protocols, and reports supporting aseptic processing, OSD manufacturing, cleaning, process validation, qualification, and computer system compliance. Ensure robust Quality…