Senior Quality Systems Specialist

PURPOSE

Be an integral part of the quality assurance organization by providing administrator support and leadership for all Genezen quality systems and users.  Address terms of systems quality and conformance to regulations and Genezen quality policies/procedures. Aid in the development of Quality Management Systems (QMS), Quality Assurance (QA) people and teams.

ESSENTIAL JOB FUNCTIONS / DUTIES

• System Administrator of Veeva Vault applications
• Subject matter expert and trainer on all Quality Management Systems, including but not limited to change control, quality events, investigation, and CAPAs
• Responsible for the development and maintenance of quality systems including a robust and continuous quality improvement system compliant with GMP and applicable to gene therapy products used in early phase clinical trials
• Resolves Veeva system problems and identifies areas for improvement
• Interface with Veeva managed services team
• Extensive knowledge of document management systems (document lifecycles, workflows, user access & permissions)
• Extensive knowledge of Quality business processes, such as electronic document management systems, document lifecycles, change control, CAPA, Deviation business processes, and learning management systems
• Maintain corporate policy and procedures for the Quality Management System in accordance with ICH Q10 model
• Communicate Veeva changes and deployments to Genezen sites
• Support customer audits and regulatory inspections as an SME for Quality Systems and Veeva applications
• Responsible for administration and user access of other Computer Systems on site
• Responsible for QA metrics and key performance indicators, including Quality Management Review
• Responsible for Genezen Document Control and Training quality systems
• Responsible for development and delivery of company training, such as Good Documentation Practices, annual GMP training, ad-hoc trainings, etc.
• Working with stakeholders, such as HR and dept heads, develop and maintain New Employee Orientation training.
• Participate as auditor in Internal Audit program
• Manage the CAPA/Deviation and Change Control Review Boards

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check and drug screen required
• Other duties as assigned

KNOWLEDGE, SKILLS & EXPERIENCE

PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment

• Occasionally exposed to loud noise levels
• Position can be a combination of remote and on-site
• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail