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Sterility Assurance Manager Jobs (NOW HIRING)

QuVa Pharma

Supervisor, Sterility Assurance 2nd Shift

Sugar Land, TX · On-site

$100K - $121K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Our Supervisor, Sterility Assurance plays a vital role in ensuring the highest quality and safety ... or management experience * Experience training personnel on aseptic techniques and appropriate ...

Integra LifeSciences

Sr Sterility Assurance Scientist

Plainsboro, NJ · On-site

$93K - $127K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

SUPERVISION RECEIVED Under direct supervision of Senior Manager, Microbiology and Sterility Assurance. ESSENTIAL DUTIES AND RESPONSIBILITIES * Serves as a Subject Matter Expert for Sterilization ...

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Sterility Assurance Manager information

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$61.5K

$123K

$158.5K

How much do sterility assurance manager jobs pay per year?

As of Aug 20, 2026, the average yearly pay for sterility assurance manager in the United States is $123,006.00, according to ZipRecruiter salary data. Most workers in this role earn between $111,500.00 and $134,500.00 per year, depending on experience, location, and employer.

What is the difference between Sterility Assurance Manager vs Quality Assurance Specialist?

AspectSterility Assurance ManagerQuality Assurance Specialist
CertificationsISO 13485, ASQ certifications, sterile processing certificationsISO 9001, ASQ certifications, industry-specific QA certifications
Work EnvironmentManufacturing, sterile processing, cleanroom settingsLaboratories, manufacturing, quality control departments
Industry UsageMedical devices, pharmaceuticals, sterile productsVarious manufacturing sectors including medical devices and pharmaceuticals

The Sterility Assurance Manager focuses on ensuring sterile processes and compliance in manufacturing environments, while the Quality Assurance Specialist oversees overall quality standards across products and processes. Both roles require similar certifications and work in regulated environments, but their specific focus areas differ.

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What are the most commonly searched types of Sterility Assurance jobs?

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Sterility Assurance Manager jobs near you

Global Sterility Assurance Systems & Standards Lead

CSL

Bradley, IL • On-site

Full-time

Re-posted 20 days ago

Job description

Global Sterility Assurance Systems & Standards Lead

Reporting to the Head of Global Sterility Assurance, this strategic position sits in the Global Quality Operations organisation. Ensuring the quality, safety and reliable supply of our products’ pipeline is critical. This newly created leadership role executes Sterility Assurance oversight and support to CSL sites and CMOs to ensure that sites operate in compliance to the highest standard regulatory expectations.

By driving sterility assurance across partnering functions, this position ensures consistent standards, proactive risk management, and global inspection readiness.

Responsibilities:

  • Provide strategic leadership to the site related to sterility assurance standards, culture and continuous improvement
  • Perform effective regulatory and business intelligence about sterile manufacturing and Sterility Assurance
  • Work collaboratively with the global sterility assurance teams to provide a holistic microbial contamination control strategy and improvement plan at the site
  • Partner closely with the global function leads as well as site leadership team, develop strategies to ensure continuous adherence to regulatory and CSL standards related to sterility assurance governance and drive improvements
  • Provide expert input to Sterility Assurance related major deviation investigations in the area of sterile filtration, aseptic filling and lyophilization and sterility, media fill and bioburden test fail
  • Proactively work with sites and global stakeholders on inspection readiness for the sites (before, during and after inspections)
  • Provide CMOs and filling strategies Sterility Support (CMO selection process, technologies intelligence…)
  • Provide strong Sterility Assurance background and support on strategic CSL projects (i.e. new filling lines selection and design)
  • Develop and lead Sterility Assurance Roadmaps for compliance and performance
  • Ensure appropriate development, implementation and maintenance of sterility assurance standards and processes consistent with global governance, regulatory requirements and industry standards.
  • Align and facilitate collaboration across Technical Operations, Quality functions, Operations, and R&D, to successfully drive aseptic excellence

Qualifications:

  • Bachelor’s degree in microbiology or biology or life sciences or equivalent relevant field
  • 8-10 years' experience in pharmaceutical manufacturing industry with direct experience executing quality assurance within a manufacturing and QC microbiology, sterility assurance context
  • Demonstrated experience in quality assurance and regulation compliance with GxP, FDA, EU and other regulatory agency guidelines
  • Experience interacting with regulatory authorities including submissions and inspections; knowledge of auditing practices and procedure

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Commonwealth Serum Laboratories logo

About Commonwealth Serum Laboratories

Sourced by ZipRecruiter

Commonwealth Serum Laboratories (CSL) is a global leader in biotechnology, based in King of Prussia, Pennsylvania. The company originates from Australia, founded in 1916 by the Australian government to service the country’s health needs. Since then, CSL has expanded operations to become a multinational specialty biotechnology company that researches, develops, and manufactures vaccines and plasma protein biotherapies. Their mission is underpinned by focused, patient-driven values. Our commitment to saving lives and protecting people's health by providing safe and effective products is a testament to the difference we are making. One of their considerate achievements includes establishing one of the largest influenza vaccine providers in the world through their brand Seqirus.

Industry

Scientific research and development services

Company size

10,000+ Employees

Headquarters location

King of Prussia, PA, US

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