Dohmen Life Science Services

Asst Director of Quality Management System (QMS) Services

Job Locations US-CO-Wheat Ridge
Job ID
2017-1884
# of Openings
1
Category
Consulting

Overview

OUR COMPANY:

Since 1858, Dohmen has been driven by the desire to get safe and effective treatments and cures to the people that need them most.  As entrepreneurs, we’ve looked for new and better ways of doing this year after year. Today, as Dohmen Life Science Services, we bring the industry’s most comprehensive service array to Medical Device, Biotech and Pharmaceutical entrepreneurs, helping them get farther faster and keeping them focused on innovations that improve lives. 

 

Our behavior is guided by five simple values –

Caring: We are empathetic and respectful.  We ask “how can I help you”

Committed: We are dedicated and persistent.  We ask “how can I make it happen”

Creative: We are inventive and imaginative. We ask “how can I do it better”

Collaborative: We are cooperative and share our knowledge. We ask “how can we achieve success”

Courageous: We’re willing to risk failure over inaction. We ask “how can I challenge myself”

This perspective defines us. How we act, how we do business, how we work with our clients and how we work with each other. They are essence of what makes us successful. They are what set us apart. 

 

THE POSITION:

The Assistant Director of Quality Management System (QMS) Services is responsible for the effective and compliant execution of the DLSS-Denver Quality Management Systems Department, within the overall Quality Management Systems Service Line, which includes:

  • Quality System Software (i.e. tools) utilized to perform QMS Services, including, but not limited to, Document Management System(s) and Training Management System(s)
  • Document Management Systems, Training Management Systems, and Quality Management System Solutions within the Pharmaceutical, Biologics, and Medical Device industries.

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POSITION SUCCESS FACTORS:

  • Technical background/experience managing and maintaining Quality System Software platforms relating to Document Management Systems, Training (or Learning) Management Systems , and Quality Management Systems
  • Ability to handle multiple internal employees and external clients simultaneously
  • Ability to manage multiple projects and deliverables in a timely fashion
  • Ability to provide project oversight/management to clients during onboarding/implementation processes
  • Ability to provide strong technical knowledge to both internal and external resources

 

ESSENTIAL FUNCTIONS:

  • Day-to-day management and execution of internal and external Quality Management System Services, including associated Quality System Software
  • Day-to-day management and development of internal resources which emphasis on leadership and creating leaders
  • Ongoing review, strategy development, and operational planning to ensure that all Quality Management System Services meet applicable regulations and standards (in conjunction with DLSS-Denver QA/RA/Operations Leadership)
  • Collaborates with organizational leadership in the establishment of associated quality objectives on an annual basis
  • Ensures internal and external projects are completed on time and meet DLSS’ quality standards
  • Ensures contractual deliverables are met with each client to it’s satisfaction
  • Participating in industry trade shows, conferences, meetings, and publications to provide an active DLSS industry presence.
  • Support and provide data as required for Management Review
  • Maintain and report accurate transactional/volume data related to QMS Services, on a minimum of a monthly basis

 

REsponsibilities:

  • Responsible to guide, mentor, and train direct reports and others within the organization
  • Responsible for management of individual and group workload to meet site objectives
  • Responsible to identify training, systems, and resource gaps to the appropriate DLSS management
  • Responsible to maintain Quality System Software in compliance with regulations and standards
  • Responsible to manage, train, and mentor QMS Solution staff
  • Responsible to identify training and resource gaps to direct supervisor
  • Daily customer management including training on ImageSilo, Windchill and the training database
  • Project Management for new QMS Solution Services customer onboarding activities.

 

 

 

Qualifications

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

  • College degree is required; management and/or life science emphasis is preferred.
  • Must have a minimum of 5 years of management experience; 7 years of management experience is preferred. Previous supervision in the medical device biologics or biopharma industry is strongly preferred.
  • Previous FDA regulatory and quality systems experience is highly desired
  • Careful attention to detail and an understanding that accuracy and precision in all aspects of work are necessary to be considered.
  • Incumbent must be able to operate in a highly structured environment and manage multiple projects simultaneously
  • Knowledge in detailed workings of document management systems (ImageSilo, Windchill, ETQ, Enovia, Agile, Master Control, etc.) and database creation/execution preferred.
  • Understanding of structure, creation and maintenance of software process workflows preferred.

 

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