Jobs
>
Chicago

    Sr Manager Global Quality Assurance - Chicago, United States - Fresenius Kabi USA, LLC

    Fresenius Kabi USA, LLC
    Fresenius Kabi USA, LLC Chicago, United States

    1 week ago

    Default job background
    Description
    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
  • IIT Research Institute

    Quality Assurance

    2 days ago

    IIT Research Institute Chicago, United States

    **For immediate consideration**: · Quality Assurance - Research Auditor · This position is responsible for performing study and facility inspections, audits/reviews of study protocols, laboratory procedures, study data, reports, and facility records to assure compliance with inte ...

  • OSI Group

    Quality Assurance

    1 hour ago

    OSI Group Chicago, United States

    Start a career with a company that knows our employees are critical to our success. 100+ years ago we started as a family-owned butcher shop in the Chicago area and have grown to be one of the largest food processing companies in the world. As our companies grows - we want you to ...

  • Worthington Steel

    Manager Quality Assurance

    2 days ago

    Worthington Steel Chicago, United States

    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 ...

  • Abbott Laboratories

    Specialist Quality Assurance

    1 week ago

    Abbott Laboratories Chicago, United States

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...

  • V15P1TALONNN

    Director of Quality Assurance

    1 week ago

    V15P1TALONNN Chicago, United States

    **Meet Our Team**: · The Senior Director Finance role is an exciting opportunity to be a key leader serving as a member of the India Leadership team and Global Finance team supporting a dynamic and high growth organization. This is a multi-faceted role handling a large team worki ...

  • Hilton

    Housekeeping Quality Assurance Coordinator

    1 week ago

    Hilton Chicago, United States

    Housekeeping Quality Assurance Coordinator - Palmer House Hilton · **Join the Palmer House Hilton as a Housekeeping Quality Assurance Coordinator and experience the opulence and beauty of Chicago's most iconic hotel.** · Be a part of 150 years of world-class service and carry it ...

  • SpiderRock Holdings LLC

    Quality Assurance Analyst I

    1 week ago

    SpiderRock Holdings LLC Chicago, United States

    **WHAT YOU WILL DO** · - Record, evaluate, and document daily automation results · - Establish test frameworks from scratch (Integration, Regression, Performance/Load) · - Manual/Automated QA testing · - Develop and document test plans based on requirements · - Assign QA release ...

  • Cook County Health & Hospitals System

    Quality Assurance Specialist, Clinical Research

    1 week ago

    Cook County Health & Hospitals System Chicago, United States

    **QUALITY ASSURANCE SPECIALIST, CLINICAL RESEARCH** · **Job Number**: ** · **Job Posting**: Apr 9, 2024, 6:57:12 PM **Closing Date**: Apr 23, 2024, 11:59:00 PM · Full-time **Shift Start Time**: 8:30 A.M. **Shift End Time**: 4:30 P.M. · **Collective Bargaining Unit**: None · **Pos ...

  • Healthcare Alternative Systems, Inc (H.A.S)

    Quality Assurance Utilization for Program Planning

    2 days ago

    Healthcare Alternative Systems, Inc (H.A.S) Chicago, United States

    **Quality Assurance Utilization for Program Planning** · 4534 S Western Ave · Chicago, IL 60609 · Full Time · **Healthcare Alternative Systems, Inc. (H.A.S.) **is a 501 (c) 3 non-profit organization providing behavioral health services to Chicago and the surrounding communities. ...

  • Neighborhood Housing Services

    Quality Assurance

    3 days ago

    Neighborhood Housing Services Chicago, United States

    Job Description · Job DescriptionBASIC JOB FUNCTIONNeighborhood Housing Services is a 48-year-old nonprofit community development organization and HUD-approved housing counseling agency focused on revitalizing historically underserved neighborhoods through homeownership. Our miss ...

  • Tibor Machine Bridgeview Facility

    Quality Assurance Inspector

    1 week ago

    Tibor Machine Bridgeview Facility Bridgeview, United States

    **Tibor Machine Products** is a leader in the contract machining industry. As one of the Midwest's largest machining companies in the south suburbs, **Tibor Machine Products** can handle volumes from prototype to production. · We are currently seeking an experienced (1st · Shift) ...

  • QntmLogic, LLC.

    Quality Assurance Manager

    1 week ago

    QntmLogic, LLC. Schiller Park, United States

    IATF ISO9001:2000 certified contract metal stamping and manufacturing company, servicing a world-class customer base in the automotive, appliance, and consumer electronics marketplace, seeks an experienced and motivated Quality Systems & Assurance Manager. POSITION RESPONSIBILITI ...

  • Great Lakes Coca-Cola

    Quality Assurance Technician

    2 days ago

    Great Lakes Coca-Cola Alsip, United States

    Overview: · Reyes Coca-Cola Bottling is a proud West Coast and Midwest bottler and distributor of Coca-Cola brands. We deliver Coca-Cola products to restaurants, sporting venues, businesses, healthcare facilities, schools, convenience stores and supermarkets. We work with iconic ...

  • Actalent

    Quality Assurance Specialist

    1 week ago

    Actalent Niles, United States Full time

    Description: · First Shift (Full Time) · Sample Inspection · Incoming Samples · Visual Inspection · Ability to lift 40 pounds · Documentation into software system · Batch Records · May be required to operate forklift · Responsible for: · Perform visual inspection of incoming mate ...

  • LSG Sky Chefs

    Quality Assurance Supervisor

    1 week ago

    LSG Sky Chefs Des Plaines, United States

    We are seeking a passionate and experienced Quality Assurance Supervisor to join our team and play a vital role in upholding our commitment to excellence. In this leadership position, you will be responsible for overseeing all aspects of our quality assurance program, ensuring co ...

  • The Vegan Copacker

    Quality Assurance Manager

    1 week ago

    The Vegan Copacker Elk Grove Village, United States

    **Overview**:Seeking an experienced and motivated individual to join our team as a Quality Assurance Manager. As the Quality Assurance Manager, you will play a crucial role in maintaining and enhancing the quality of our food products. You will be responsible for developing, impl ...

  • Illinois Municipal Retirement Fund (IMRF)

    Quality Assurance Auditor

    2 days ago

    Illinois Municipal Retirement Fund (IMRF) Oak Brook, United States

    **Deadline for internal applicants: 04/23/2024** · **INTRODUCTION** · The Illinois Municipal Retirement Fund (IMRF) provides death, disability, and pension retirement benefits to employees of local governments and school districts in Illinois (with the exception of the City of Ch ...

  • Iya Foods

    Quality Assurance Manager

    2 days ago

    Iya Foods Naperville, United States

    **About us** · Iya Foods is a small business in Gluten Free Food Manufacturing in Naperville, IL. We are an innovative and hard working team. · Our work environment includes: · - Growth opportunities · - Casual work attire · - On-the-job training · **Job Summary**: · **Responsibi ...

  • Speed Express

    Quality Assurance Representative

    1 hour ago

    Speed Express Elk Grove Village, United States

    **Position Overview**: As a QA Representative for Exception Package Processing at SpeedX, you will play a vital role in maintaining the integrity and efficiency of our logistics operations. Working closely with both our operations team and customer service department, you will be ...

  • Uline

    Quality Assurance Analyst

    1 week ago

    Uline Glenview, United States

    **Quality Assurance Analyst** · **Corporate Headquarters** · **12575 Uline Drive, Pleasant Prairie, WI 53158** · Unlock your full potential as a Quality Assurance Analyst at Uline Join a collaborative environment where you'll design, develop, and deliver custom solutions to big c ...