Quality Management Systems Manager (QMS Manager)
About The Position
The Quality Management Systems Manager works cross-functionally to champion and deliver continuous improvement initiatives for the systems, processes, and functions that comprise the GxP Quality Management System (QMS) on the Veeva Basic platform. The role supports compliance with regulatory requirements, industry standards, and company policies across the development, manufacturing, testing, release, and distribution of clinical and commercial pharmaceutical and device products. It provides expertise on quality systems and related processes across the regulated environment, and coordinates and guides material and change control review boards while assessing process and system risks.
Requirements
- Bachelor's degree in life sciences, pharmacy, chemistry, or a related field.
- At least eight years of experience in the regulated pharmaceutical and/or biotechnology industry, including at least five years in a leadership position with increasing responsibility.
- Hands-on expert-level experience with full Veeva Vault or Veeva Basics implementations.
- Full knowledge of GxP regulations, including GMP (FDA, EU, etc.), ICH guidelines, and ISO standards.
- Experience working with global teams and in regulated environments.
- Experience managing post-implementation enhancements and supporting continuous improvement.
- Demonstrated project management, organization, execution, and priority-setting skills.
- Proven experience developing and/or improving QMS, QE, and compliance programs, including leading material and change control review boards.
- Excellent communication, interpersonal, and leadership skills, including the ability to work with diverse professionals and influence stakeholders at all levels.
- Extensive experience using electronic document and quality management systems (EMDS/EQMS).
- Attention to detail and ability to manage multiple priorities.
Nice To Haves
- Experience implementing the Veeva Vault Quality Suite, ideally QualityDocs, QMS, and Training.
- Veeva Vault Administrator or Vault Quality certification.
Responsibilities
- Identify, champion, and drive cross-functional improvement initiatives to enhance and streamline quality systems, frameworks, and associated processes, including material and change control review boards.
- Engage stakeholders to ensure quality systems are continuously monitored and improved to strengthen compliance and operational efficiency.
- Plan, coordinate, and lead internal audits, including preparation, execution, response coordination, and follow-up on observations.
- Coordinate partner response development and oversee commitments, investigations, and CAPAs.
- Develop, review, and approve controlled documents in alignment with regulatory requirements, guidance, and company standards.
- Facilitate quality management reviews and support the development of registers, KPIs, metrics, dashboards, and routine reporting mechanisms.
- Apply project management and execution methodologies to prioritize, plan, and deliver quality system and compliance initiatives with stakeholders.
- Monitor evolving regulatory requirements and guidance, and work with stakeholders to assess and address potential quality system impacts.
- Foster a culture of quality, collaboration, and accountability within the team and across the organization.
- Perform additional duties as requested.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
