Title: Director, Quality (Contamination Control and Microbial Excellence) - Remote, Ireland - Remote, Milano, Italy - Remote, France - Remote, United Kingdom Full time Remote 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 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. DESCRIPTION: The Director, Quality (Contamination Control and Microbial Excellence) at Thermofisher plays a critical role in ensuring that all GMP operations maintain the highest standards of contamination control, sterility assurance and microbiological excellence. This position is a collaborative role, working with fellow CCME team members, Operations, MSAT, Engineering and quality colleagues. The role is responsible for the definition and implementation of global policies and standards related to contamination control, sterility assurance and microbiology across all PSG sites to ensure alignment, standardization and compliance with current regulatory requirements. ROLE AND RESPONSIBILITIES: - Support site based CCME colleagues to develop, implement, and maintain site contamination control strategies based on contamination control risk assessment in alignment with global quality procedures and EU GMP Annex 1, FDA 21 CFR, ISO and PIC/S. - Provide subject matter expertise (SME) in microbiology, microbiological methods, contamination control, aseptic processing, Environmental Monitoring, cleanroom design, cleaning and disinfection and other relevant areas required by site CCME teams and corporate quality management. - Support global review of EM trends from the PSG network and work with site teams to remediate adverse trends and maintain environmental control in all cleanrooms. - Provide above-site support and direction to PSG sites for complex deviation or laboratory investigations related to Microbiology, Contamination Control and Sterility Assurance. Where appropriate, support with CAPA plan definition, preventive measures and continuous improvement initiatives. - Provide above-site support and direction to PSG sites for complex risk assessments related to Microbiology, Contamination Control and Sterility Assurance. - Provide guidance during facility and process design, including design led contamination controls and material/personnel and waste flows. Provide SME input into the qualification of manufacturing equipment and cleanroom that impact CCME including proper selection and validation of sterilization processes (e.g., autoclaves, SIP, filter integrity testing). - Inspection Readiness - Support digitalization and innovation across PSG sites REQUIREMENTS: - Bachelor’s or advanced degree in Microbiology, Pharmaceutical Sciences, Biotech, or a related field. - 8–10 years experience in supporting sterile/low bioburden pharmaceutical manufacturing and/or microbiology roles. - Strong understanding of aseptic manufacturing, cleanroom classification, disinfection, and contamination control. - Deep knowledge of GMP, Annex 1 (2022 revision), FDA aseptic guidance - Understanding of barrier technologies (RABS, isolators) and their implementation - Effective communicator, able to influence and collaborate with cross-functional teams - Prior experience with regulatory inspections and audit defense. - Experience with CCS implementation preferred

• Provide strategic leadership and oversight of data management activities across multiple clinical programs, ensuring high-quality, inspection-ready data deliverables. • Lead and develop data management staff while fostering collaboration across internal teams and external partners, including CROs and vendors. • Oversee the end-to-end data management lifecycle, including study start-up, database build, data review, and database lock. • Drive vendor oversight, study execution, and cross-functional coordination to ensure timelines, budgets, and quality expectations are met. • Establish and enhance data management standards, SOPs, and processes to ensure compliance with GCP, ICH, and regulatory requirements. • Provide strategic input into resource planning, budgeting, and continuous improvement initiatives across the function.

• Lead end-to-end Clinical Data Management activities for assigned clinical studies from study start-up through database lock and archival • Provide operational leadership for study timelines, deliverables, risks, and quality across internal teams and external vendors • Oversee key CDM activities including: Database build and validation, eCRF design and review, Edit check specifications, Data review and cleaning, External data reconciliation (e.g., PK, biomarkers, central labs, imaging), Database lock activities, Data transfers for statistical analysis and regulatory submissions • Review and approve key CDM documentation including: Data Management Plans (DMPs), Data Review Plans, CRF Completion Guidelines, Vendor data transfer specifications, Database validation documentation • Ensure clinical data are accurate, complete, consistent, and inspection-ready in compliance with timelines and regulatory requirements • Partner cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Clinical Development, Regulatory, and Quality to support study execution and submission readiness • Contribute to the development and implementation of CDM standards, SOPs, processes, and best practices • Support standardization initiatives aligned with CDISC standards and evolving industry practices • Drive proactive risk identification, issue escalation, and resolution across study teams and vendors • Lead and manage CRO/vendor relationships for data management activities, including oversight of quality, timelines, budgets, and performance metrics • Support governance meetings and vendor performance reviews to ensure accountability and continuous improvement • Collaborate with cross-functional stakeholders to support data review, reconciliation, and clinical data integrity • Support inspection readiness activities, audits, and health authority inspections related to clinical data management • Support process optimization, automation, and innovation to improve operational efficiency and data quality • Contribute to building a collaborative, high-performing CDM function aligned with company values

• Own end‑to‑end execution for assigned Therapeutic Area(s), spanning steady-state operations, launches, and enterprise change initiatives • Serve as the single point of accountability for field execution once initiatives go live • Monitor execution health and assess field readiness as initiatives move from deployment into sustained operation • Translate execution health signals into informed decisions and corrective actions • Proactively identify risks, friction, or breakdowns and navigate timely escalation and resolution • Partner with planning, enablement, and infrastructure teams to ensure processes, tools, training, and sequencing are in place ahead of field deployment • Capture insights and lessons learned from execution to continuously strengthen FOPE standards