17.06.25

QMS Administrator

  • Permanent
  • USA
  • CDMO

QMS Administrator

Are you a QMS Administrator looking for an exciting opportunity with an organization where you can have an impact on global health and wellness?

We are looking for an individual who will lead and oversee the management, maintenance, configuration and validation of the electronic Quality Management Systems (eQMS) at our FDA approved CDMO facility. Are you a person who thinks out of the box and who is looking for a new challenge? Do you naturally create new ways to deliver exceptional results? We want to meet you!

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.

Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients for yourself, and for INCOG’s clients.

Job Functions:

  • Provide oversight and direction for the eQMS and drive solution delivery to meet systems. development, continuous improvement/enhancement, validation, and management activities.
  • Partner with the Quality Systems and Quality Compliance teams to implement best practices, develop training, and adoption of the eQMS system.
  • The QMS Administrator will be the lead for the overall system design, system capabilities, and vendor management, incorporating the site’s needs for QMS processes and master data management. This role will act as the System Owner for related system/document reviews and approvals (e.g. CMMS, Kneat).
  • Execute and lead multiple projects and technical work assignments as a point of contact for project stakeholders.
  • Improve business processes and efficiency by proactively pursuing/building business cases and requirements for new and improved functionality.
  • Partner with key stakeholders across the organization to execute program improvements and plans; including but not limited to: user interface, information access, and reporting.
  • Execute and update documentation for the support of LIMS and QC Laboratory systems to aid in system adoption by personnel and ensure assets are reliable, accessible, and secure.

Candidate Requirements:

  • 5+ years of progressive Quality Systems management experience.
  • 5+ years of experience managing electronic Quality Management Systems; 3+ year of Administration.
  • Proven experience driving complex projects to completion highlighting the use of robust project management skills.
  • Commanding knowledge of building SOPs, systems/training documentation, Quality and Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices to support working within a regulated environment.

Why INCOG?

  • Paid time off, based on tenure
  • 11 paid holidays
  • 401(k) plan with company match up, vested immediately
  • Choice of health & wellness plans
  • FSA and HSA options
  • Onsite wellness facility
  • Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Reach out to Harley at harley@leadcandidate.com to find out more!

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

Apply here
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