About this opportunity
About the job:
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Sanofi has added two new Modulus Facilities to our global industrial footprint. These production units represent the future of manufacturing. They allow us to increase our capacities while making production more flexible and respectful of the environment.
Fully digitalized, our Modulus Facilities will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. Our facilities will help improve people’s lives by giving them faster access to more treatments.
In this context, we are seeking a highly motivated QC Specialist to join our team and play a key role in establishing and operating a state-of-the-art QC laboratory at our new Singapore site. This position offers an exciting opportunity to contribute to the successful start-up of a new facility and ensure compliance with global quality standards.
Main Responsibilities
1. Environmental Monitoring Operations
Perform routine Environmental Monitoring (EM) activities, including sampling, data review, trending, and documentation in accordance with GMP requirements.
Develop EM sampling plans for routine monitoring, BSC EM sampling, isolator EM sampling, aseptic qualification, and equipment qualification activities.
Coordinate and manage the EM sampling schedule to ensure all routine and ad hoc activities are completed on time.
Review EM sampling results in LIMS to ensure data accuracy, completeness, and compliance with GMP requirements.
Forecast media requirements and provide procurement estimates to ensure sufficient inventory for EM activities.
2. Equipment & Qualification
Lead qualification and requalification (IQ/OQ/PQ) activities for EM equipment.
Review and approve qualification documents, protocols, and reports.
Manage the calibration of air samplers and particle counters, including scheduling, vendor coordination, and documentation.
3. Quality & Compliance
Lead and support investigations related to EM excursions, deviations, contamination events, CAPAs, and change controls.
Act as the document owner for EM-related SOPs, Work Instructions (WIs), and other GMP documents, ensuring they remain current and compliant.
Perform quarterly EM trending to monitor environmental performance and support GMP compliance.
Manage the microbial isolate conservation program, including isolate selection, culture maintenance, and trending.
Support validation activities
4. Technical Leadership & Support
Act as the Subject Matter Expert (SME) for Environmental Monitoring, providing technical guidance and troubleshooting support to EM personnel and cross-functional teams.
Serve as the EM trainer by developing and delivering training to ensure personnel competency and compliance.
Maintain competency in QC Microbiology laboratory bench testing to provide operational support when required.
Participate in cross-functional meetings to coordinate EM-related activities and provide technical input.
Work closely with Manufacturing, Engineering, Validation, QA, and other stakeholders to support EM-related activities and ensure GMP compliance.
About You
Education and experience
Education: Degree in Microbiology, Life Sciences, or a related scientific discipline
Experience: Proven experience in a pharmaceutical or biopharmaceutical microbiology laboratory environment for about 5-8 years. Ability to work collaboratively in a fast-paced environment
Technical Skills: Strong knowledge in Environmental Monitoring and cGMP regulations (EU/US).
Functional Skills: Experienced in Risk-Based Approach and Operational Excellence
Soft Skills: Good communication capabilities; ability to drive continuous improvement and lead cross-functional collaboration
Languages: Proficiency in English
Pursue progress , discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 1008 comparable Quality roles across 131 biopharma companies.
Salary context
193 of 1008 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1008 comparable roles
+ 42 more countries
Seniority mix
498 of 1008 peers have a known seniority level
Therapeutic area mix
2 of 1008 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.