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Director, Quality (Contamination Control and Microbial Excellence)

May 11, 2026

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION:The Director, Quality (Contamination Control and Microbial Excellence) at Thermofisher plays a critical role in ensuring that all GMP operations maintain the highest standards of contamination control, sterility assurance and microbiological excellence. This position is a collaborative role, working with fellow CCME team members, Operations, MSAT, Engineering and quality colleagues.The role is responsible for the definition and implementation of global policies and standards related to contamination control, sterility assurance and microbiology across all PSG sites to ensure alignment, standardization and compliance with current regulatory requirements.ROLE AND RESPONSIBILITIES:<ul><li>Support site based CCME colleagues to develop, implement, and maintain site contamination control strategies based on contamination control risk assessment in alignment with global quality procedures and EU GMP Annex 1, FDA 21 CFR, ISO and PIC/S.</li><li>Provide subject matter expertise (SME) in microbiology, microbiological methods, contamination control, aseptic processing, Environmental Monitoring, cleanroom design, cleaning and disinfection and other relevant areas required by site CCME teams and corporate quality management. </li><li>Support global review of EM trends from the PSG network and work with site teams to remediate adverse trends and maintain environmental control in all cleanrooms.</li><li>Provide above-site support and direction to PSG sites for complex deviation or laboratory investigations related to Microbiology, Contamination Control and Sterility Assurance. Where appropriate, support with CAPA plan definition, preventive measures and continuous improvement initiatives.</li><li>Provide above-site support and direction to PSG sites for complex risk assessments related to Microbiology, Contamination Control and Sterility Assurance.</li><li>Provide guidance during facility and process design, including design led contamination controls and material/personnel and waste flows. Provide SME input into the qualification of manufacturing equipment and cleanroom that impact CCME including proper selection and validation of sterilization processes (e.g., autoclaves, SIP, filter integrity testing).</li><li>Inspection Readiness</li><li>Support digitalization and innovation across PSG sites</li></ul>REQUIREMENTS:<ul><li>Bachelor’s or advanced degree in Microbiology, Pharmaceutical Sciences, Biotech, or a related field.</li><li>8–10 years experience in supporting sterile/low bioburden pharmaceutical manufacturing and/or microbiology roles.</li><li>Strong understanding of aseptic manufacturing, cleanroom classification, disinfection, and contamination control.</li><li>Deep knowledge of GMP, Annex 1 (2022 revision), FDA aseptic guidance</li><li>Understanding of barrier technologies (RABS, isolators) and their implementation</li><li>Effective communicator, able to influence and collaborate with cross-functional teams</li><li>Prior experience with regulatory inspections and audit defense.</li><li>Experience with CCS implementation preferred</li></ul>

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...