Six Sigma Quality Program Manager jobs in Bayonne, NJ

Six Sigma Quality Program Manager leads and manages Six Sigma projects. Plans and develops guidelines, targets, and standards used for monitoring and measuring results. Being a Six Sigma Quality Program Manager incorporates Six Sigma methodology and analytics into organizational operations in order to accomplish business objectives. Coaches and trains teams in the utilization and deployment of Six Sigma tools and principles. Additionally, Six Sigma Quality Program Manager requires a bachelor's degree. Requires Six Sigma Black Belt certification. Typically reports to a director. The Six Sigma Quality Program Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Six Sigma Quality Program Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Manager, Quality
  • Alvogen
  • Morristown, NJ FULL_TIME
  • SUMMARY OF POSITION

    The Manager is a member of the US Quality department. In interacting primarily with Alvogen's external business partners / CMOs, exercising Quality Management Systems and GMP Compliance oversight of them, the Manager is responsible for supporting the administration and implementation of Alvogen's Quality Management Systems and adhering to all associated documentation requirements for the Alvogen Inc. and the Almatica Pharma Inc. business units.

    ORGANIZATION STRUCTURE

    The Manager, US Quality reports directly to the Director, Third Part Quality US. There are no reports, direct or otherwise to the Manager, US Quality.

    RESPONSIBILITIES

    Primary responsibilities of this role include, but are not limited to, the following:

    1. Administer and/or Support the Finished Product / Bulk Product Release System.
      1. Execute the Alvogen Inc. and Almatica Pharma Inc. material release procedure(s). Manage release priorities per business deadlines. Work directly with manufacturers and partners to resolve related questions/issues.
      2. File, retrieve, and maintain organized records.
    2. Support Alvogen U.S. R&D technical transfer and initial commercial / validation activities with external business partners / CMOs.
    3. Track metrics for external business partners / CMOs on change controls, deviations, complaints, audits, product releases and rejections and other Third Party Quality Key Performance Indicators.
    4. Review Annual Product Reports / Product Quality Reports.
    5. Change Management Program:
      1. Process change controls for all systems requiring change control support (e.g. specifications for raw materials, drug product intermediates and finished drug products, validation protocols and reports, master production and packaging records, cleaning records, and analytical methods).
      2. Maintain change control electronic records in EQMS.
      3. Review, assess, and approve change controls as required by SOP's.
      4. Support training of company personnel on change control system.
    6. Support the design and implementation of change control process improvements where opportunities are identified.
    7. Support the Document Control Systems, such as Standard Operating Procedures, Forms, and similar document management programs as directed by Quality Management.
    8. Support the corporate Training Program, when / if needed.
    9. Keeps abreast of industry regulations and cGMP trends. Stays informed of FDA and ICH Guidelines related to GMP.
    10. Support the corporate audit program as needed / required.

    QUALIFICATIONS

    Position requires the following education and qualification prerequisites:

    1. Bachelor's degree in a technical field preferred. A minimum of 3-5 years' prior experience in a pharmaceutical manufacturing facility involving change control, quality standards, or quality assurance for manufacturing, packaging, quality control, and validation.
    2. Has knowledge of GMP quality systems, predicate rule, US FDA/ICH guidance documents, commonly used concepts, practices and procedures within a particular field.
    3. Experience with injectable (sterile/aseptic) manufacturing / filling processes.
    4. Must hold strong interpersonal skills and the ability to work well with diverse groups. This includes the ability to work in a team environment. Must also display strong organizational skills with the ability to lead team meetings and to manage multiple systems at one time. Strong technical writing, computer and clerical skills also required. Further display the ability to work independently with little or no supervision and plan and accomplish set goals.

    Physical Demand Factors

    1. While performing the duties of this job, the Manager, US Quality is required to sit and work at a computer for extended periods of time.
    2. Is regularly required to talk and listen.
    3. Approximately 5-10% business travel required to external Contractor Manufacturing Organization (CMO) / Business Partner sites, or to attend professional development training seminars - as needed / directed.

    GMP DECISION-MAKING AUTHORITY

    Independent decision-making activities will be performed by the Manager, US Quality for all the quality management system elements outlined in the Responsibilities section of this Job Description.

    We are an EEO Employer, including disability & vets.


    EOE/M/F/Vet/Disability

     

  • 10 Days Ago

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MANAGER, QUALITY
  • Valcor Engineering Corporation
  • Springfield, NJ FULL_TIME
  • Accountability: Plan, direct, manage and coordinate quality and reliability requirements throughout the Company. Has direct responsibility exercised through subordinates, for inspection and quality co...
  • 17 Days Ago

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Manager, Quality
  • Norwich Pharmaceuticals Inc
  • Morristown, NJ FULL_TIME
  • SUMMARY OF POSITION The Manager is a member of the US Quality department. In interacting primarily with Alvogen’s external business partners / CMOs, exercising Quality Management Systems and GMP Compl...
  • 18 Days Ago

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Quality Manager
  • WHIPPANY ACTUATION SYSTEMS LLC
  • Whippany, NJ FULL_TIME
  • Quality Manager Whippany Actuation Systems is looking for a dynamic leader with extensive AS9100 and AS9110 knowledge to oversee our highly skilled team of Quality Engineers and Quality Inspectors to ...
  • 1 Month Ago

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Quality Manager
  • Whippany Actuation Systems
  • Whippany, NJ FULL_TIME
  • Quality Manager Whippany Actuation Systems is looking for a dynamic leader with extensive AS9100 and AS9110 knowledge to oversee our highly skilled team of Quality Engineers and Quality Inspectors to ...
  • 1 Month Ago

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Physical Therapist
  • Sigma Inc
  • Bergen, NJ CONTRACTOR,FULL_TIME
  • (phone number removed) - Physical Therapist - North Bergen, NJ - 14 Weeks Contract Sigma Healthcare team is looking for an experienced Physical Therapist to work at our client's facility in North Berg...
  • 19 Days Ago

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0 Six Sigma Quality Program Manager jobs found in Bayonne, NJ area

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Quality Manager
  • AtkinsRealis
  • New York, NY
  • Why join us? It's an exciting time at AtkinsRalis! We are rapidly growing in the US. Our company purpose is to build a b...
  • 3/29/2024 12:00:00 AM

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Quality Assurance Supervisor- Laboratory
  • RWJ Barnabas
  • Jersey City, NJ
  • Quality Assurance Supervisor - Full Time - Days In this role, Quality Assurance Supervisor oversees and maintains respon...
  • 3/28/2024 12:00:00 AM

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Director of GCP/QA
  • Advanced Recruiting Partners
  • New York, NY
  • Job Description Determine risk-based intervals for audits of non-GMP vendors and ensure compliance with agreed-upon sche...
  • 3/28/2024 12:00:00 AM

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KYC Quality Control Analyst
  • Sumitomo Mitsui Banking Corp
  • Jersey City, NJ
  • SMBC Group is a top-tier global financial group. Headquartered in Tokyo and with a 400-year history, SMBC Group offers a...
  • 3/27/2024 12:00:00 AM

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Quality Assurance, Associate Director or Senior Manager
  • Anavex
  • New York, NY
  • The Associate Director (AD) or Senior Manager (SM), Quality Assurance (QA) is responsible for ensuring compliance with a...
  • 3/27/2024 12:00:00 AM

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Quality Manager
  • Arcadis Global
  • New York, NY
  • Arcadis is seeking a Senior Quality Manager to join and support our team on a large program in New York. Arcadis is the ...
  • 3/27/2024 12:00:00 AM

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Quality Assurance Manager, Customer Support
  • BlueVine
  • Jersey City, NJ
  • **Quality Assurance Manager, Customer Support** at BlueVine Jersey City, NJ **About BlueVine** BlueVine is a high-growth...
  • 3/26/2024 12:00:00 AM

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Manufacturing Engineer
  • Thea Energy
  • Kearny, NJ
  • About Thea Energy: Thea Energy is leveraging recent breakthroughs in stellarator physics and engineering to create a fas...
  • 3/25/2024 12:00:00 AM

Bayonne /beɪˈjoʊn/ bay-OWN is a city in Hudson County, New Jersey, United States. Located in the Gateway Region, Bayonne is situated on a peninsula located between Newark Bay to the west, the Kill Van Kull to the south, and New York Bay to the east. As of the 2010 United States Census, the city's population was 63,024, reflecting an increase of 1,182 (+1.9%) from the 61,842 counted in the 2000 Census, which had in turn increased by 398 (+0.6%) from the 61,444 counted in the 1990 Census.[21] Bayonne was originally formed as a township on April 1, 1861, from portions of Bergen Township. Bayonne ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Six Sigma Quality Program Manager jobs
$134,968 to $173,492
Bayonne, New Jersey area prices
were up 1.6% from a year ago

Six Sigma Quality Program Manager in Los Angeles, CA
Six Sigma and Lean enable organizations to measure and analyze production processes, to eliminate waste and to evolve their management structures in order to motivate employees and improve quality and productivity.
January 16, 2020