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Sr Manager - Quality Systems at Merz North America Inc

Posted in Science 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Franksville, Wisconsin





Job Description:

The Sr. Manager, Quality Systems is responsible for developing and implementing computer based Quality Systems for Medical Devices, Pharmaceuticals and Cosmetics processes and operating controls. This role manages large scale Quality System projects within the established scope and schedules required to meet corporate objectives.   Responsible for the following functions within the Quality System: Training, Document Control, Electronic QMS (EQMS) Platform, Configuration, Validation and Support. Position will operate as a liaison among the various functions and the Quality Operations department to assure strategic alignment and compliance.

Major duties

Manage staff and resources


  • Manage scheduling of staff, resources and procedures to support Merz Quality Systems functions (Training, Document Control, EQMS)

Support Quality System functions


  • Support other Quality System functions as assigned by Quality Management that are related to documentation creation/revision, Nonconformance review, Out of Specification, Corrective and Preventative Actions, Risk Management, Training, Supplier Quality, product complaint investigations, audits, and other tasks as directed.

Identifies new quality improvement initiatives


  • Identifies new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies.

Quality Systems SME


  • Acts as a local expert and resource on quality systems.

Evaluate and implement new technologies


  • Evaluate and implement new technologies per Quality System Standards, Quality System Regulations, and other company procedures around which the Quality System is developed.

Participate in inspections and audits


  • Participate with federal, state, and local regulatory officials during regulatory inspections.

Coach and mentor employees / Make hiring decisions


  • Coach and mentor employees to optimum performance, and recruit and interview qualified applicants, ensure appropriate new-hire training and orientation, and provide on-going training and development of Quality Team.

Perform internal and vendor audits


  • Perform internal and vendor quality system audits as applicable.

Facilitate, review and/or approve protocols and reports


  • Facilitate, review and/or approve the development of protocols and final reports for product development or other quality projects.

Other duties as assigned

Education


  • Bachelor’s Degree Required

  • Bachelor’s Degree in Business Administration or Life Sciences

  • Master’s

Professional experience


  • Minimum 6 years Medical Device or Pharmaceutical Manufacturing and/or other similarly regulated industry experience. Required

  • ASQ Certification as a Quality Auditor, Quality Technician, Quality Engineer, or equivalent.

Knowledge, skills and abilities (incl. languages)


  • Knowledge of regulatory requirements for medical device / pharmaceutical organization Required

  • Computer skills in Microsoft Word, Excel, PowerPoint, Visio and Access; Adobe; and Quality System Management Software. Required

  • Ability to work with company staff and communicate effectively throughout the organization is essential. Required

  • Experience with FDA, European agency regulations, cGMP regulations, Laboratory Information Management Systems (LIMS) and Quality Management software is highly preferred. Required

  • Performance of vendor and/or internal audits. Required

  • Ability to prepare testing protocols and reports, operating documents and procedures Required

  • Ability to work with little or no supervision, and make effective decisions. Required    

   Knowledge of methods


  • Knowledge of Good Manufacturing Practice and Good Documentation Practice principles Required       

Personal skills


  • Highly effective communication skills. Ability to interact with organization wide employees at all levels. Required

  • Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required. Required

  • Ability to effectively lead and manage a team or department Required

  • Strong technical writing and general problem-solving skills required. Required

Experience


Required


  • 6 year(s): Medical Device or Pharmaceutical Manufacturing and/or other similarly regulated industry experience.


Preferred


  • ASQ Certification as a Quality Auditor, Quality Technician, Quality Engineer, or equivalent

Education


Required


  • Bachelors or better


Preferred


  • Masters or better

  • Bachelors or better in Business Administration

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

See job description