Manager, Quality Systems in Grafton, WI

Date Posted: 11/10/2020

Job Snapshot

  • Employee Type:
    Full-time
  • Location:
    Grafton, WI
  • Job Type:
    Quality
  • Experience:
    Manager with Direct Reports
  • Date Posted:
    11/10/2020

Job Description

Description

The Manager, Quality Systems, serves as the site primary contact for the sites Quality Management System.  The position leads a team which proactively coordinates the efficient implementation of the quality management system and drives continuous improvement initiatives.  The Manager, Quality Systems leads a team that controls the cGMP documentation and maintains a Quality System which meets the regulatory, quality, and compliance requirements.
The Manager, Quality Systems, in cooperation and alignment with the other members of the Quality Assurance department, provides quality oversight to the site to ensure compliance and support the various quality initiatives.  Major Duties and Responsibilities 1.
Serve as site primary contact for the site’s Quality Management System.
• Support development, implementation, and management of site’s Quality Management System and related processes to ensure compliance with FDA cGMP, ICH guidelines, and others
• Identifies and implements efficiency and effectiveness improvements to QMS processes.
• Collaborate with Global Quality Organizations to identify and implement system enhancements, share best practices, and facilitate alignment across sites/businesses
• Work cross functionally to support the creation and revision of policies and procedures in support of the sites quality management system
• Provide support and guidance to quality and site personnel on QMS matters.
• Monitor and track and trend deviations, CAPAs, Change Controls to ensure proper documentation, timely closure, and suitable steps identified to prevent recurrence. 2.
Provide or coordinate company-wide training on general quality principles and specific procedural requirements and maintains the quality training system. 3.
Lead the documentation process: 1. Ensure that controlled cGMP documents (including, but notlimited to product labels, production and cleaning master batch records, logbooks, notebooks, registers, worksheets, and forms) are properly generated, secured, issued, distributed, returned, reconciled, and archived; 2. Maintain current and archived versions of controlled documents and records (paper and electronic) per established processes; 3. Ensure that procedures are reviewed/approved within assigned cycle time; 4. Maintain site documentation (Site Master File, Quality Manual, site presentation, quality databases) up to date; 4.
Collect, trend, and communicate the site quality KPI’s and related improvement plans. 5.
Keeps Quality Director updated on trends, anticipating problems and escalating potential issues. 6.
Assists in implementation of the site Data Integrity program and GMP quality platforms (for example, TrackWise and Master Control). 7.
Assists Quality Director with client and FDA audits of the facility, as necessary. 8.
Performs other related duties as assigned or directed.

Qualifications

Qualifications Education and/or Experience
• Bachelor's Degree in Chemistry, Biology or related sciences
• Minimum of five years of relevant experience in Quality in a cGMP/FDA regulated environment.
• Experience and understanding of FDA regulations and ICH guidelines
• Additional knowledge of cGMP regulations for other regulated markets is optional but preferred.

Job: Quality
Primary Location: Grafton, Wisconsin
Schedule: Full-time
Job Posting: 11/10/2020
Shift Type:

AMRI is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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