Senior Manager, Quality Systems

Aveo Pharmaceuticals • Boston, MA

90d

About The Position

The Senior Manager, Quality Systems serves as a subject matter expert providing support with respect to the monitoring, maintenance, and continuous improvement of the Veeva Quality Vault suite of Computerized Systems. Develop, maintain and deliver training materials on Training, Document Control, Deviation, CAPA, and Change Control workflows. This role will also support implementation, monitoring, maintenance and continuous improvement of other GxP computer systems. Additional responsibilities include supporting internal, third party, and regulatory agency audits and inspections.

Requirements

• BS/BA or equivalent experience.
• 5+ years relevant work experience in the biotech/pharmaceutical industry.
• Experience with Veeva Quality Vault; Document Management, Learning Management and Quality Systems is required.
• Experience in validation and configuration of systems to support business needs.
• Proven experience with training delivery, including excellent presentation, public speaking, and facilitation skills.
• Excellent organizational, interpersonal, written and verbal communication skills.
• Extremely high level of professionalism and superior attention to detail.
• Able to demonstrate flexibility when presented changing priorities.
• Able to demonstrate a sense of initiative and ownership, including skills to carry out responsibilities with minimal to no supervision.
• Ability to collaborate and interact with internal and external stakeholders at all levels.
• Excellent skills within MS Word and Office suite.
• Demonstrated working knowledge of GxP, ICH guidelines, and global regulations as they pertain to biotech/pharmaceutical industries.

Responsibilities

• Serve as a System Administrator and subject matter expert for Veeva Quality Vault, troubleshooting technical issues to support business needs and continuous improvement initiatives.
• Generate and revise SOPs, work instructions, job aids, and training material for operation and administration of QMS workflows.
• Support internal, third party, and regulatory agency audits and inspections.
• Participates in inspection readiness and inspection support activities.
• Represents Quality Assurance on project teams and in meetings.
• Promotes a Quality Culture by supporting innovation, teamwork and efficiency within the organization.
• Collaborates cross-functionally to create, manage, and report on Key Performance and Key Quality Indicators (KPI and KQI) and trends.
• Manage the daily functions of the Veeva QualityDocs system including processing document change controls, completing document review requests, and resolving documentation issues.
• Serve as a resource for GxP staff on document management procedures and technology.
• Collaborate cross-functionally to assess document management needs and inform stakeholders of best practices.
• Ensure compliance with SOP creation, revision, and biennial reviews, including the timely revision and distribution of documentation to the appropriate users.
• Facilitate GxP document and record lifecycle management, including document storage, retention, disposition, and document retrieval in accordance with regulations, AVEO procedures, and industry best practices.
• Provide training to users and modify user profiles and permissions in Veeva.
• Develops and maintains role-based curricula and issues training assignments as well as supports maintenance and improvements to the Veeva learning management system.
• Coordinate with Functional Area Management (FAM) to determine training needs, issue training solutions, and monitor training completion.
• Ensure that the evidence of training completion is documented, filed, and readily available.
• Collaborate with HR to ensure that CVs and JDs are obtained, and are maintained in a current, consistent, and compliant format for all GxP staff.
• Collaborate with FAM and Subject Matter Experts to design and develop course content.
• Deliver GxP related training content in a variety of formats including classroom, web-based, and blended learning.
• Other responsibilities as assigned.

What This Job Offers

• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree