IT Business Systems Manager – GxP CSV Operations

Position Summary:

The IT Business Systems Manager for GxP CSV Operations is the IT point person providing centralized operational oversight and adherence to GxP IT CSV (Computer Systems Validation) processes and operations in direct partnership with Quality Validation.  This position will coordinate with IT GxP System Owners for the on-going support and processes for system changes, change controls, periodic reviews and other on-going operational activities.  This position will focus on ensuring efficient operational processes are used across the different types of technology platforms used at Apellis, enabling the cross-teams to focus on business system processes and functional details. 

Location: Hybrid Waltham, MA 

Key Responsibilities Include:

•  Identify best practices and assist with training and process optimization efforts for continuous improvements for IT CSV activities in collaboration with IT GxP System Owners and the Quality Validation team. Foster the adoption of best practices and process optimizations across the cross-functional teams and across disparate technology platforms.
• Ensure that system change updates are being documented and processed effectively, and accurately across the different technology platforms used at Apellis.
• Work with the various IT GxP System Owners for the on-going support and processes for system changes, change controls, periodic reviews and other on-going activities.
• IT CSV operational support activities may include performing in the role of an IT project manager on small or medium-sized operational change activities.
• Maintain the centralized knowledge repository for IT CSV processes, best practices, and lessons learned across the organization and different technology platforms.
• Maintain a CSV portfolio dashboard for timelines, resources, and operational efforts
• Assist with “inspection readiness” for GxP IT Systems, including be the “back room” facilitator for IT. Be the centralized IT GxP point person for internal and external compliance assessments/ audits /inspections.

 

Education, Registration & Certification:

 

Experience:

• Degree in computer science, technology, operations, or related disciplines preferred.
• 5-7+ years pharmaceutical/biotech required
• Experience working in a GxP regulated environment;
• Excellent knowledge of 21 CFR Part 11/Annex 11 compliance and Computer System Validation (CSV) and Computer System Assurance (CSA), and IT SLDC best practices

 

 

Skills, Knowledge & Abilities:

•  Proven track record of supporting GxP systems and thinking holistically about the business processes critical to company success across multiple systems and departments.
• Experience with different types of GXP System technical infrastructure and architecture including private tenant versus multi-tenant web-based GxP SaaS platforms and on-premise versus cloud-based deployments.
• Experience as a business analyst, including identification of non-technical business requirements and translating specifications into solution designs
• Solid project management skills, with experience in managing multiple initiatives simultaneously in a fast-paced, changing environment
• Analytical mindset with the ability to identify process inefficiencies, assess risk, and implement actionable solutions.
• Extensive experience working in a team-oriented, collaborative environment.

 

 

Benefits and Perks:

Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit https://apellis.com/careers/benefits/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therap