Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Senior Manager, QA Validation – Media Network

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a rewarding career with us.

Role Intent

Aseptic program leadership: Assess, lead, and continually improve the aseptic process/behavior program to ensure robust contamination control and GMP compliance.Validation governance: Lead the Quality review and approval of validation documents, ensuring alignment to regulatory expectations.  Conduct internal audits in the area of validation requirements, seeking opportunities for systemic improvement.

Key Responsibilities

Aseptic ExcellenceEstablish and maintain a standardized aseptic behavior framework, including procedures, training, observations, and metrics across all sites.Perform periodic risk assessments of aseptic operations; implement mitigation strategies, and verify effectiveness.Lead gemba/behavioral observation programs and raise systemic issues; manage and report key performance metrics to leadership.Explore and train on current industry knowledge and changing expectations to maintain status as a subject matter authority.Validation Quality OversightOwn QA oversight for process, cleaning, equipment, utilities, computerized systems, etc.Approve validation and qualification outputs; ensure documented rationale, statistical adequacy, and data integrity.Harmonize validation standards, templates, and practices; drive cross-site consistency and change control governance.Quality Systems & ComplianceEnsure alignment with corporate QMS, GMP, GxP, and relevant regulations/standards (e.g., ISO 13485, MDSAP, FDA/ICH).Partner with Operations, Engineering, MSAT, and QC on tech transfers, change controls, deviations, and investigations with validation impact.Review regulatory trends; update policies/SOPs and training to maintain compliance.Leadership & Partner ManagementLead a matrixed cross-site team; provide mentoring, workload prioritization, and competency development in validation and aseptic practices.Present performance, risks, and improvement plans to senior leadership; secure resources and drive accountability.

Qualifications

Bachelor’s or Master’s in a science/engineering field; advanced degree preferred.5+ years in GMP environments with strong validation and aseptic manufacturing experience; multi-site experience preferred.Demonstrated expertise in validation lifecycle management, aseptic behavior programs, internal auditing, and CAPA leadership.Strong knowledge of applicable regulations and standards; excellent communication, influence, and ability to independently lead project teams.Good understanding of statistical techniques, with six sigma certification a plus

Key Performance Indicators

Aseptic behavior adherence and observation effectiveness across sites.Validation output quality (first-pass approval rate, timeliness, lifecycle review completion).Audit outcomes (findings severity, CAPA closure on-time, reoccurrence rate).Cross-site standardization adoption and sustained compliance metrics.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Compensation and Benefits

The salary range estimated for this position based in Florida is $118,100.00–$177,200.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards