Job Description

We are looking for a

Principal Quality System Manager

to provide the definition, planning, coordinating and conducting of all aspects of the quality management system in compliance with ISO 9001.


The primary responsibility will be to assure the definition, implementation and maintenance of the quality system in compliance with Executive Management expectations and company policies. The position is also accountable for hosting and facilitating third-party regulatory and customer audits as the liaison and authority for the organization on matters concerning the quality system.


This is a challenging role with diverse responsibilities. This individual must have the ability to quickly build credibility within the quality systems and compliance community, Executive Management, and customers. This individual must also possess strong collaboration and influence management skills to partner effectively across business operating units.

Basic Qualifications:

5 years + of experience in managing all aspects of a quality management system 5 years + of expertise in documenting, implementing, and maintaining ISO 9001 compliant quality management systems 5 years + history of facilitating customer and other regulatory authority audits of varying levels of complexity, including escalation of follow-up activities as warranted and audit closure

Preferred Qualifications:

Bachelor's degree in a life sciences-related discipline is desired Excellent understanding of the software development life cycle Technical proficiency with general business applications such as MS Office, SharePoint, and Jira Ability to work with multi-cultural, global teams Ability to monitor and advise on initiatives and compliance with defined operational procedural standards Ability to take ownership for and work independently with accuracy and high-capacity output (results and performance driven) Demonstratable auditor attributes and behaviors Strong interpersonal and relationship management skills with the ability to effectively communicate (verbal and written communication skills) Collaboration in a team environment Excellent planning and co-ordination skills Be able to readily adapt to changes in priorities and project schedules Contribute to, and promote positive working relationships across key disciplines Attention to detail and a concern for quality Desired familiarity with regulatory pharmaceutical compliance and GxP

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