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.
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
Skills
- 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
Benefits
- Variable annual bonus based on company, team, and/or individual performance results in accordance with company policy
- 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