Senior Manager, Quality Systems

• Bachelor’s degree in life sciences, engineering, pharmacy, or a related discipline required; advanced degree preferred
• 7+ years within GMP Quality Assurance, Quality Systems, technical operations quality, or manufacturing quality required specifically within the pharmaceutical or biotechnology industry
• Demonstrated hands-on experience administering or supporting electronic Quality Systems required, preferably Veeva Vault applications such as QualityDocs, Training, and eQMS modules
• Hands-on experience initiating, reviewing, managing Quality Events in an electronic Quality Management System, including Change Controls, Deviations, CAPAs, and Continuous Improvement records.

• Strong understanding of quality system processes, including document control, training management, deviations, CAPA, change control, quality risk management, investigations, and regulatory inspection readiness.

• Demonstrated technical writing and document-management skills, with experience authoring or revising SOPs, work instructions, forms, and controlled Quality System documents.

• Strong computer, organizational, and analytical skills required
• Strong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and cultures

Responsibilities include but are not limited to

1. 1Manage and maintain a compliant state of the electronic Quality Systems, including but not limited to Document Management, Training, Change Control, Deviations, and CAPA.
2. 2Provide day-to-day support for Quality Events, including Change Controls, Deviations, CAPAs, and Continuous Improvement records, from initiation through review, approval, implementation, and closure.
3. 3Monitor Quality Event workflows, record quality, aging, and due dates; identify bottlenecks, facilitate timely escalation, and support sustainable process improvements.
4. 4Draft, revise, route, and periodically review SOPs, work instructions, forms, and other controlled documents to maintain alignment with current processes and applicable GxP requirements.
5. 5Ensure harmonization across GxP domains (GMP/GLP/GCP) and alignment with applicable regulations/standards.
6. 6Provide operational support to Technical Operations, Regulatory Affairs, Clinical Operations, and Medical Affairs by troubleshooting Veeva Vault and other GxP system issues, coordinating issue resolution, assisting users, and supporting approved workflow improvements.
7. 7Administer the GxP training program and related Quality processes, including Veeva Vault Training, role-based curricula, training assignments, periodic review activities, and maintenance of inspection-ready training records.
8. 8Ensure that systems and business processes meet organizational business needs and regulatory requirements.
9. 9Provide day-to-day administration and user support for document lifecycle activities within Veeva Vault QualityDocs, including document creation, review and approval workflows, periodic reviews, and archival activities.
10. 10Develop, compile, analyze, and maintain Quality System metrics and trends, including cycle times, overdue items, training compliance, audit outcomes, CAPA effectiveness results, and open improvement actions; prepare and present assigned materials for Quality Management Review to support performance monitoring, risk escalation, and continuous improvement.
11. 11Partner with process owners and cross-functional stakeholders to clarify Quality System requirements, resolve workflow issues, reinforce procedural compliance, and promote consistent use of the eQMS.
12. 12Provide oversight and support for additional GxP-regulated systems, as needed. Perform other duties as assigned.