About the role
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
About Revvity
At Revvity, “impossible” is inspiration, and ""can't be done"" is a call to action. Revvity provides health science solutions, technologies, expertise and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what’s possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more. With more than $3 billion in revenue and over 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 190 countries. Learn more at www.revvity.com
About the role
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
About Revvity
At Revvity, “impossible” is inspiration, and ""can't be done"" is a call to action. Revvity provides health science solutions, technologies, expertise and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what’s possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more. With more than $3 billion in revenue and over 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 190 countries. Learn more at www.revvity.com