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.
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
Bachelor’s Degree Required
Bachelor’s Degree in Business Administration or Life Sciences
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
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
6 year(s): Medical Device or Pharmaceutical Manufacturing and/or other similarly regulated industry experience.
ASQ Certification as a Quality Auditor, Quality Technician, Quality Engineer, or equivalent
Bachelors or better
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.