Quality Document Sys Mgmt. Spec 2,

Roles & Responsibilities

Key responsibilities:

• Actively participate in GCS compliance initiatives with Readiness and Quality project teams.
• Assists GCS Readiness Project Managers in preparing procedures, work instructions, and GCS documentation.
• Ensures GCS documents are produced in accordance with corporate/BU procedures, and regulatory standard/guidance. Assists with writing content when required.
• Assists GCS Readiness project managers with documentation and process reviews, including scheduling meetings, facilitating SME input, collating documentation input, and tracking completion of deliverables in accordance with standard project management practices.
• Plans, coordinates, and executes all Veeva Vault activities to ensure compliance with regulations and standard work instructions procedures
• Creates and maintains documentation for GCS on how to use Veeva Vault
• Attains and maintains required expertise in all databases that house product data for the platform (Veeva Vault, SAP, SharePoint)
• Attains mastery of all BD processes for governing GCS documentation
• Serves as subject matter expert and resource for GCS on documentation, ensuring GCS documentation is controlled and approved, and make optimizations as needed.
• Identifies opportunities to streamline or improve processes

Experience Required

• Two or more years of experience in project management
• Prior experience within a regulated industry (e.g., medical device, pharma, automotive, aerospace) is preferred
• Managed/supported projects cross-functionally in an iterative, fast paced environment
• Experience with technical writing or documentation review preferred
• Excellent verbal and written communication skills required
• Strong analytical, problem-solving, and interpersonal skills
• High attention to detail while managing multiple complex deliverables and stakeholder groups
• Ability to learn quickly, deal with ambiguity, take initiative and achieve results
• Demonstrated proficiency with MS Office skills, particularly in PowerPoint, Excel, and Word. Proficiency with SharePoint, Jira, and Confluence preferred.
• Proven organization and time management skills
• Location: prefer San Diego candidate or candidate located in Pacific or Mountain Time Zones

Skills & Certifications

Professional Skills & Key Competencies

• Excellent professional/business writing skills and the ability to communicate correctly and concisely in English
• Strong technical skills and experience with using a document management system like Veeva Vault or SAP
• Ability to understand system operations and dependencies to effectively set-up, manage, and troubleshoot problems with a documentation management system
• Ability to gain new technical skills quickly
• Strong customer service skills and positive attitude
• Ability to communicate complex technical concepts in layman’s terms
• Advanced skills with Microsoft Office products
• Ability to meet tight deadlines and handle changing priorities

Eligibilities & qualifications

• Bachelor’s Degree in Engineering, Technology, or Life Sciences preferred.