Incog Biopharma Services Careers - QMS Administrator

We are seeking a QMS Administrator that is experienced, agile, and collaborative and has maturity, confidence, strategic thinking, and sound judgment/decision making skills. The QMS Administrator will work closely with the Sr. Manager of Quality Assurance, and the Quality Systems and Quality Compliance teams to support, enhance, and maintain compliance for the Quality Management System and all supporting environments and validation states.

This position requires a passion for Quality Systems, and systems configuration/management. Project management and business analyst experience is critical to the role, as well as the ability to work both independently and in a team environment at all levels of the organization. The QMS Administrator will be influential in championing and developing Quality initiatives, specifically regarding the eQMS. They will possess a demonstrated ability to influence positive outcomes with minimal direct supervision.

Essential 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.
• Provide administrative support and liaison with partners for assigned systems and supporting applications by completing tasks such as computer software assurance, periodic reviews, access reviews, and system administration.
• Lead implementations and changes by discovery, defining, configuring, testing, and documenting integrated business processes.
• Coordinate and leverage internal and external resources for support and project implementation.
• Provide digital plant subject matter expertise (SME), to multi-function teams, advises stakeholders on application configurations, data integrity, cyber security, and defend work before regulatory agencies.
• Ensure alignment with directives and industry guidelines for applications.
• Provide ad-hoc support for Quality Events team, internal customers, and clients, on the processing and routing of Deviation investigations, Change Controls, CAPAs, etc.

Special Job 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.
• B.S. in Life Sciences, Computer Science, or equivalent experience.

Additional Preferences:

• Certification in any Quality processes or SaaS platform management.

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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