Senior Project Manager, Quality

Thermo Fisher Scientific

Quality execution leader for strategic manufacturing and validation programs at Thermo Fisher Scientific. Collaborating across multiple functions to drive quality-related activities for complex projects.

Posted 6/10/2026full-timeRemote • District of Columbia • 🇺🇸 United StatesSenior💰 $130,000 - $194,950 per yearWebsite

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Serve as the quality execution leader for strategic manufacturing, validation, and infrastructure programs
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 while protecting Thermo Fisher Scientific's commitment to delivering high-quality, compliant products to our customers

Requirements

What you’ll need

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
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
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
Lean Six Sigma, continuous improvement, or operational excellence experience preferred
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

Benefits

Comp & perks

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At 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 policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Management SystemsChange controlsRisk assessmentsValidation protocolsTechnical documentationQuality system processesAnalytical skillsProblem-solvingLean Six SigmaContinuous improvement

Soft Skills

LeadershipCommunicationRelationship buildingDecision-makingAccountabilityProject managementInfluencingOrganizational skillsAbility to manage multiple prioritiesTechnical writing

Certifications

PMPASQ Certified Quality Engineer (CQE)Certified Quality Auditor (CQA)