Senior Manager, Validation and Aseptic Processing

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

Establish and maintain a standardized aseptic behavior framework, including procedures, training, observations, and metrics across all sites.

Own QA oversight for process, cleaning, equipment, utilities, computerized systems, etc.

Ensure alignment with corporate QMS, GMP, GxP, and relevant regulations / standards (e.g., ISO 13485, MDSAP, FDA / ICH).

Lead a matrixed cross-site team; provide mentoring, workload prioritization, and competency development in validation and aseptic practices.

Qualifications

Key Performance Indicators

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.

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 :