Senior Project Manager, Quality

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.

Responsibilities:

• Serve as the quality execution leader for strategic manufacturing, validation, and infrastructure programs
• Ensure quality deliverables remain aligned to project milestones, customer commitments, regulatory requirements, and business objectives
• Drive execution of quality-related activities required to advance complex projects, including change controls, risk assessments, validation readiness, customer change notifications, quality approvals, and compliance initiatives
• Provide leadership across multiple functions to ensure quality requirements are integrated into project execution while maintaining compliance, protecting supply continuity, and supporting business growth
• Directly influence successful execution of large-scale manufacturing initiatives, product transfers, facility upgrades, and new business opportunities

Requirements:

• Advanced 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 industry
• 5+ years of experience leading cross-functional projects, programs, or quality initiatives in a regulated manufacturing environment
• Demonstrated experience managing change controls, risk assessments, deviations, investigations, and quality system processes
• Strong 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 documentation
• Demonstrated ability to assess quality impact associated with equipment modifications, process changes, product transfers, facility upgrades, and manufacturing improvements
• Experience leading change control activities and facilitating cross-functional impact assessments
• Strong technical writing skills, including development of customer change notifications, quality memorandums, risk assessments, technical justifications, and regulatory documentation
• Experience serving as a customer-facing quality representative and effectively communicating quality-related changes, risks, and presenting project updates
• Ability to build strong working relationships across Quality Assurance, Quality Engineering, Quality Control, Engineering, Validation, Manufacturing, Regulatory Affairs, Supply Chain, and Site Leadership
• Experience identifying, escalating, and driving resolution of quality, compliance, and execution risks impacting project delivery
• Demonstrated ability to influence decision-making and drive accountability without direct authority
• Strong analytical, problem-solving, and risk-based decision-making capabilities
• Experience partnering with Documentation Control and Training organizations to ensure timely implementation of SOPs, controlled documents, training curricula, and quality system requirements
• Proficiency with electronic Quality Management Systems, MasterControl, TrackWise, SAP, Document Management Systems, and Microsoft Office applications
• Experience supporting audit readiness, inspection preparedness, and proactive quality gap identification and remediation activities
• Strong written and verbal communication skills with the ability to communicate effectively at all organizational levels, including customers, site leadership, and executive stakeholders
• Ability to manage multiple priorities and deliver quality-related project milestones in a fast-paced, highly regulated environment
• Up to 20% travel required
• Preferred Fields of Study: Engineering, Chemistry, Biology, Pharmacy, Life Sciences, Quality Systems, or related scientific/technical field
• PMP certification, ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification preferred
• Lean Six Sigma, continuous improvement, or operational excellence experience preferred