QA Manager, Quality Management Systems (Contractor)

Summary of Position

 The Manager, Quality Management Systems is responsible for the global management and support of Quality Management Systems, including Document Management, Training, Quality Events/CAPA, Investigations, Effectiveness Checks, and Change Control.  The primary role for this position will be to identify and support enhancements and /or new releases of currently used electronic QMS systems (Trackwise), conduct training, update relevant procedures, and report metrics for QE /CAPA.

This role will also support Vendor Qualification, Audits, and Supplier Quality Management by assisting with metrics, running system reports, and attending / facilitating QMS Board meetings. 

Roles and Responsibilities

1.           Support and track enhancements or new releases of electronic QMS systems (Trackwise) or implementation of new electronic QMS systems. This includes system requirement setting, execution of UATs, updating required SOPs, creation/updates to Training materials and training roll out. Support all documentation supporting IQE/CAPA, Supplier Quality and Audits processes in Trackwise.  This includes creation of procedures, guidelines, process maps, training, and execution of UAT testing for implementation. 

2.           Develop and report metrics on Quality Events, CAPA, and Effectiveness Checks. Support creation of metrics for other QMS System areas, including Training and Document Management (SOPs), Change Control, Supplier Quality and Audits as needed.

3.           Provide status reports, including relevant metrics to department management and follow-up on QE / CAPA items to ensure timely completion. Support other QMS systems, as required.

4.           Support various Management Review forums.  This includes QMS Board meetings, as necessary, including QE / CAPA, Document Management & Training Committee, Change Control, etc. In addition, supporting Quality Council meetings which includes follow up metrics reports/slides and reports as needed.

5.           Partner with key functional areas in the organization to enhance the use of the electronic QMS system and to ensure consistent application of system practices. This includes SOP revisions, changes in Trackwise System and Master Control, as needed.

6.           Create, review, and approve Quality Event, CAPA and Effectiveness check records.

7.           Perform other duties as assigned and support QMS team members with other work as needed. 

8.           Support Back Room activities for Regulatory inspections with document request processing.

Qualifications and Background Requirements 

Educational Requirements

 •            BA or BS in a related field is preferred

Professional Work Experience

 •            A minimum of 5-10 years’ experience in Quality & Compliance.

•            Experience in quality metrics reporting, analysis, and process improvement techniques.

•            Self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment is required

•            Ability to perform in a team and matrix organization, as well as adapt to a dynamic environment is required

•            Strong communication with demonstrated competency interfacing with cross functional business areas.

•            Proficient with computer usage and application such as Microsoft Word, Powerpoint and Excel, Quality Management Systems, Trackwise, and Master Control.

Location

 •            This position will be remote. 

 

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