[Remote] Senior Project Manager, Quality

Note: The job is a remote job and is open to candidates in USA. Thermo Fisher Scientific is a leader in healthcare, dedicated to making the world healthier, cleaner, and safer. As a Senior Project Manager in Quality, you will lead strategic manufacturing and validation initiatives, ensuring quality deliverables align with project milestones and regulatory requirements while collaborating across various functions.ResponsibilitiesServe as the quality execution leader for strategic manufacturing, validation, and infrastructure programsEnsure quality deliverables remain aligned to project milestones, customer commitments, regulatory requirements, and business objectivesDrive execution of quality-related activities required to advance complex projects, including change controls, risk assessments, validation readiness, customer change notifications, quality approvals, and compliance initiativesProvide leadership across multiple functions to ensure quality requirements are integrated into project execution while maintaining compliance, protecting supply continuity, and supporting business growthDirectly influence successful execution of large-scale manufacturing initiatives, product transfers, facility upgrades, and new business opportunitiesSkillsAdvanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in Quality, Validation, Engineering, Manufacturing, Regulatory Affairs, Project Management, or related experience within a regulated industry5+ years of experience leading cross-functional projects, programs, or quality initiatives in a regulated manufacturing environmentDemonstrated experience managing change controls, risk assessments, deviations, investigations, and quality system processesStrong understanding of Quality Management Systems and applicable regulations (FDA, ISO 13485, ISO 9001, cGMP)Experience supporting validation activities, including review and approval of User Requirements Specifications (URS), risk assessments, validation protocols, validation summary reports, and technical documentationDemonstrated ability to assess quality impact associated with equipment modifications, process changes, product transfers, facility upgrades, and manufacturing improvementsExperience leading change control activities and facilitating cross-functional impact assessmentsStrong technical writing skills, including development of customer change notifications, quality memorandums, risk assessments, technical justifications, and regulatory documentationExperience serving as a customer-facing quality representative and effectively communicating quality-related changes, risks, and presenting project updatesAbility to build strong working relationships across Quality Assurance, Quality Engineering, Quality Control, Engineering, Validation, Manufacturing, Regulatory Affairs, Supply Chain, and Site LeadershipExperience identifying, escalating, and driving resolution of quality, compliance, and execution risks impacting project deliveryDemonstrated ability to influence decision-making and drive accountability without direct authorityStrong analytical, problem-solving, and risk-based decision-making capabilitiesExperience partnering with Documentation Control and Training organizations to ensure timely implementation of SOPs, controlled documents, training curricula, and quality system requirementsProficiency with electronic Quality Management Systems, MasterControl, TrackWise, SAP, Document Management Systems, and Microsoft Office applicationsExperience supporting audit readiness, inspection preparedness, and proactive quality gap identification and remediation activitiesStrong written and verbal communication skills with the ability to communicate effectively at all organizational levels, including customers, site leadership, and executive stakeholdersAbility to manage multiple priorities and deliver quality-related project milestones in a fast-paced, highly regulated environmentUp to 20% travel requiredPreferred Fields of Study: Engineering, Chemistry, Biology, Pharmacy, Life Sciences, Quality Systems, or related scientific/technical fieldPMP certification, ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification preferredLean Six Sigma, continuous improvement, or operational excellence experience preferredBenefitsVariable annual bonus based on company, team, and/or individual performance results in accordance with company policyA choice of national medical and dental plans, and a national vision plan, including health incentive programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees