Provide the definition, planning, coordinating and conducting of all aspects of the quality management system in compliance with ISO 9001.
Assure the definition, implementation and maintenance of the quality system in compliance with Executive Management expectations and company policies.
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.
Quickly build credibility within the quality systems and compliance community, Executive Management, and customers.
Possess strong collaboration and influence management skills to partner effectively across business operating units.

Requirements

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
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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

quality management systemISO 9001auditingdocumentationimplementationmaintenancesoftware development life cycleregulatory complianceGxPoperational procedural standards

Soft skills

collaborationinfluence managementinterpersonal skillsrelationship managementcommunication skillsplanningcoordinationadaptabilityattention to detailownership