Sr Manager Global Quality Assurance

2 weeks ago

Chicago, United States Fresenius Kabi USA, LLC Full time

Job Summary The Sr. Manager, Manufacturing Quality US Supply Sites will assure that all activities associated with manufacturing of products within the portfolio of all sites manufacturing for distribution in the US comply with the Manufacturing Quality Assurance concept developed by the Competence Center Manufacturing Quality (CC MQ). The oversight will also extend to the assurance of coverage of the Laboratory Quality Assurance (LQA) activities as also outlined in the current global annex.

This position will have primary responsibility for the NAM sites and will work in close cooperation with colleagues in Europe and ROW, including other Competency Centers such as those responsible for Microbiology & Aseptic Technique and QC Standards. The position will have no direct reports but must work closely with the MQA heads at each site in scope and within the CC MQ, MQA Team.

Also included in the scope of responsibility is implementation and revision of the global SOPs to ensure sustainability of the training and harmonization of best practices that were established by the Compliance Enhancement Program (CEP). Responsibilities

This Sr Manager will serve as ambassador of Senior Managements vision of the desired Quality Culture behaviors. Responsible for contributing to the planning and execution of the MQA / LQA concept. Develops standards for MQA / LQA activities to promote harmonization across all regional sites and USSS. Implementation of the best practice standards established by Competency Centers throughout the Fresenius Kabi organization. Establish MQA / LQA touchpoints throughout entire manufacturing and assurance of oversight of the drug testing processes. Participate in ensuring global SOP implementation has been prioritized at all regional sites. Establish and monitor KPIs such as Right First Time (RFT), investigation timeliness and 28-day batch release. Provide weekly monitoring of all global complaints for signals and trends. Annual review assignment for formal check and content-wise check of Periodic Quality Reports for all current Fresenius Kabi sites. Participate in the annual review of the efficiency and impact of the MQA / LQA activities. Assignment of additional activities based off inspection readiness or inspection results, as determined by Senior Management. Requirements * Accomplished quality leader with relevant experience in pharmaceutical manufacturing operations.

o Significant quality manufacturing experience, 10+ years

o Thorough knowledge of cGMPs, ICH guidelines, other standards as applicable

o Proven leadership ability as influencer

* Bachelor's Degree required. Advanced degree in science or engineering preferred.

* Ability to effectively interact with NAM manufacturing and MQA teams to align with Competency Center strategies, including:

o Mentorship, knowledge transfer

o Decision making and troubleshooting

o GEMBA walks, 5S, Internal Audits, inspection readiness

o Investigations, root cause analyses, CAPAs, effectiveness checks

o Shop floor checks of batch documentation

* Demonstrated understanding of manufacturing system technology and ability to establish sustainable quality management system partnership.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance,

disability,401K

with company match, andwellness program. Fresenius Kabi is an Equal

Opportunity/Affirmative

Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

#J-18808-Ljbffr

  • Global Head of Quality Assurance

    4 weeks ago

    Chicago, United States Merieux NutriSciences Full time

    Global Head of Quality AssuranceChicagoRegular MERIEUX NUTRISCIENCESAs a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food,...

  • Global Head of Quality Assurance

    2 weeks ago

    Chicago, Illinois, United States Merieux NutriSciences Full time

    Global Head of Quality AssuranceChicagoRegular MERIEUX NUTRISCIENCESAs a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food,...

  • Global Head of Quality Assurance

    2 weeks ago

    Chicago, Illinois, United States Merieux NutriSciences Full time

    Global Head of Quality Assurance Chicago Regular MERIEUX NUTRISCIENCES As a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food,...

  • Global Head of Quality Assurance

    3 weeks ago

    Chicago, United States Merieux NutriSciences Full time

    Global Head of Quality Assurance Chicago Regular MERIEUX NUTRISCIENCES As a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food,...

  • Global Head of Quality Assurance

    4 weeks ago

    Chicago, United States Mérieux NutriSciences Full time

    As a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food, environment and consumer goods. External growth has been a key pillar of...

  • Quality Assurance Manager

    2 weeks ago

    Chicago, United States Sol-Millennium Medical Group Full time

    Sol-Millennium is a global healthcare company dedicated to improving the safety and well-being of patients and healthcare providers. With innovative solutions and a commitment to excellence, we strive to deliver products that enhance the quality of care. Our team is passionate, driven, and committed to making a difference in the healthcare industry.Job...

  • Quality Assurance Manager

    2 weeks ago

    Chicago, United States Sol-Millennium Medical Full time

    **About Sol-Millennium**: Sol-Millennium is a global healthcare company dedicated to improving the safety and well-being of patients and healthcare providers. With innovative solutions and a commitment to excellence, we strive to deliver products that enhance the quality of care. Our team is passionate, driven, and committed to making a difference in the...

  • Manager Quality Assurance

    3 weeks ago

    Chicago, United States Worthington Steel Full time

    The Manager, Quality Assurance (QA) is responsible to oversee all QA processes and QA personnel for the Tempel Chicago campus which includes QC lab, as well as incoming and outgoing quality. This position is responsible to manage the internal quality system, ensure processes and procedures affecting quality are effective, documented, and followed, and for...

  • Vendor Manager, Quality Assurance

    3 weeks ago

    Chicago, United States Request Technology Full time

    Vendor Manager, Quality Assurance Salary: Open + Bonus Location: Chicago, IL Hybrid: 3 days on-site, 2 days remote *We are unable to provide sponsorship for this role* Qualifications Bachelor’s degree 10 years of experience in software development and software quality assurance including the management of vendors and outsourced resources globally. 3 years...

  • Vendor Manager, Quality Assurance

    4 weeks ago

    Chicago, United States Careeraddict Full time

    Quality Assurance Manager Salary: Open + Bonus Location: Chicago, IL Hybrid: 3 days on-site, 2 days remote *We are unable to provide sponsorship for this role* Qualifications Bachelor's degree 10 years of experience in software development and software quality assurance including the management of vendors and outsourced resources globally. 3 years of...

  • Vendor Manager, Quality Assurance

    2 weeks ago

    Chicago, United States Request Technology Full time

    Vendor Manager, Quality AssuranceSalary: Open + BonusLocation: Chicago, ILHybrid: 3 days on-site, 2 days remote*We are unable to provide sponsorship for this role* QualificationsBachelor’s degree10 years of experience in software development and software quality assurance including the management of vendors and outsourced resources globally.3 years of...

  • Vendor Manager, Quality Assurance

    4 weeks ago

    Chicago, United States Request Technology Full time

    Vendor Manager, Quality Assurance Salary: Open + Bonus Location: Chicago, IL Hybrid: 3 days on-site, 2 days remote *We are unable to provide sponsorship for this role* Qualifications Bachelors degree 10 years of experience in software development and software quality assurance including the management of vendors and outsourced resources globally. 3 years...

  • Vendor Manager, Quality Assurance

    4 weeks ago

    Chicago, United States Request Technology, LLC Full time

    Vendor Manager, Quality AssuranceSalary: Open + BonusLocation: Chicago, ILHybrid: 3 days on-site, 2 days remote*We are unable to provide sponsorship for this role*QualificationsBachelor’s degree10 years of experience in software development and software quality assurance including the management of vendors and outsourced resources globally.3 years of...

  • Vendor Manager, Quality Assurance

    3 months ago

    Chicago, United States Request Technology, LLC Full time

    Vendor Manager, Quality AssuranceSalary: Open + BonusLocation: Chicago, ILHybrid: 3 days on-site, 2 days remote*We are unable to provide sponsorship for this role*QualificationsBachelor’s degree10 years of experience in software development and software quality assurance including the management of vendors and outsourced resources globally.3 years of...

  • Manager - Quality Assurance

    2 weeks ago

    Chicago, Illinois, United States United Airlines Full time

    United Airlines offers an exciting opportunity to be part of a team dedicated to becoming the leading airline in aviation history. With a global presence spanning hundreds of locations and thousands of employees, our mission of 'Connecting People, Uniting the World' goes beyond transport. We are committed to fostering diversity and inclusivity in all aspects...

  • Manager - Quality Assurance

    3 weeks ago

    Chicago, United States United Airlines Full time

    **Description**: There’s never been a more exciting time to join United Airlines as we’re on a path toward becoming the best airline in aviation history! Our shared purpose, "Connecting People, Uniting the World," is more than getting people from one place to another. As a global company that operates in hundreds of locations worldwide, with thousands of...

  • Site Quality Assurance Manager

    4 weeks ago

    Chicago, United States Zoetis Spain SL Full time

    Site Quality Operations Manager page is loaded Site Quality Operations Manager Apply locations Chicago Heights time type Full time posted on Posted Yesterday job requisition id JR00014478 This position reports directly to the Site Head of Quality and will serve as Quality Assurance (QA) Operations Manager for the Site. This role has primary responsibility...

  • Manager of Enterprise Quality Assurance

    4 weeks ago

    Chicago, United States CareerAddict Full time

    *We are unable to sponsor for this permanent Full time role* *Position is bonus eligible* Prestigious Global Firm is currently seeking a Manager of Enterprise Quality Assurance. Candidate will lead the Quality Assurance (QA) function for the Information Technology Team. This leader will own quality strategies, implementation and institutionalization of...

  • Quality Assurance Manager

    4 weeks ago

    Chicago, United States Kirkland & Ellis Full time

    About Kirkland & Ellis At Kirkland & Ellis, we are united in our ambition and drive to move forward. We share core values that help us achieve excellence: collaboration, talent empowerment, service, inclusion, respect and gratitude. Our people are our greatest asset, and we invest in the brightest talent and encourage a diversity of perspectives and...

  • Associate Director, Quality Assurance

    4 weeks ago

    Chicago, United States Xeris Pharmaceuticals, Inc. Full time

    Overview: The Associate Director, Quality Assurance will provide cross functional quality assurance support to manufacturing, quality control, clinical and non-clinical operations. This role will be responsible for QA business processes supporting GMP, GCP and GLP compliance, regulatory inspection readiness, quality planning and continuous improvement...