Sterility Assurance Expert
About this opportunity
#LI-OnsiteLocation: Morris Plains, NJ, United StatesRelocation Support: This role is based in Morris Plains, NJ, United States. Novartis is unable to offer relocation support: please only apply if accessible. This is an opportunity to play a critical role in protecting patients by shaping and defending sterility assurance strategies for advanced aseptic manufacturing. As the Sterility Assurance Expert, you will provide hands‑on technical leadership across aseptic processing, microbial control, environmental monitoring, and contamination investigations, ensuring every decision is scientifically sound, data‑driven, and inspection‑ready. Partnering closely with Operations, Quality, and Technical teams, you will serve as a trusted authority who drives risk‑based decisions, strengthens compliance with evolving regulatory expectations, and continuously improves sterility assurance programs in a highly regulated, mission‑critical environment.
Key ResponsibilitiesServe as site sterility assurance expert for aseptic processing and microbial control programsDesign, maintain, and improve sterility assurance strategies aligned with global regulatory expectationsLead sterility‑related deviations, contamination investigations, and risk‑based decision makingOwn environmental and personnel monitoring strategies, including trending, escalation, and continuous improvementAuthor, review, and approve sterility assurance documentation, validations, and technical rationalesRepresent sterility assurance during regulatory inspections, audits, and quality governance forumsPartner cross‑functionally to resolve sterility risks and strengthen inspection readiness and complianceEssential RequirementsBachelor’s degree in a scientific or related technical fieldExtensive experience supporting sterility assurance programs in regulated biopharmaceutical manufacturing environmentsDemonstrated participation in regulatory health authority inspections (e.g., FDA, EMA, MHRA, TGA) within a commercial GMP manufacturing facility, including defense of sterility assurance, aseptic processing, or microbial control programs is required.Minimum of five years direct experience supporting commercial aseptic manufacturing operations within a cGMP-regulated environment, including routine production support, deviation management, change control, and real-time risk assessment required.Proven experience leading sterility‑related investigations, environmental monitoring programs, and corrective action planningStrong knowledge of global regulatory expectations, including United States and European health authority requirementsAbility to apply scientific judgment, analyze complex data, and communicate clear, compliant recommendationsDesirable RequirementsExperience supporting sterility assurance activities for aseptic cell or gene therapy manufacturing is a plusThe pay range for this position at commencement of employment is expected to be between $108,500 and $201,500 per year; however, while salary ranges are effective for a defined period, fluctuations in the job market may necessitate adjustments. Final pay determinations will depend on a variety of factors, including but not limited to geographic location, experience level, knowledge, skills, and abilities. The total compensation package may also include other elements, such as a performance‑based bonus and a full range of medical, financial, and other benefits, including retirement programs and paid time off. Details of participation in these benefit plans will be provided if an offer of employment is made. Employment with Novartis is at‑will, and the company reserves the right to modify compensation at any time based on individual, business, or market factors.To learn more about the culture, rewards and benefits we offer our people click here.
Job details
How this role compares
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We currently track 644 comparable Quality roles across 85 biopharma companies.
Salary context
110 of 644 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.
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Seniority mix
309 of 644 peers have a known seniority level
Therapeutic area mix
0 of 644 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
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How we calculate "similar"
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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.