Job Description

JOB TITLE: GXP APPLICATION AND OPERATIONS MANAGER

Employment Type: Full Time

REPORTS TO: Sr. Manager, IT GxP & Quality Applications

THE CELITO TEAM

The Celito Team architects the buildout of simplified, integrated, and compliant technology stacks. With both consulting and products, our expertise can help our customers save time and money as they move from strategic Clinical & Quality management all the way to widespread and profitable commercialization.

JOB OVERVIEW

The GxP Application and Operations Manager role is responsible for analyzing business needs, identifying suitable systems to implement, and maintaining GxP compliance where applicable. This role is also responsible for operational support of GxP systems such as system configuration and resolving general system issues to support daily business activities for systems.

RESPONSIBILITIES AND DUTIES

• Lead cross functional discussion with business stakeholders and quality unit for the selection and implementation of systems (ELN, LIMS, eDMS, LMS, RIM, eCTD, eTMF, CTMS, Pinnacle 21, SAS). Adhere to industry best practices for change and release management. Manage implementation of the system from initiation to go-live

• Help strategize with validation lead, validation deliverables such as requirement specifications/validation plans/protocols/reports/test scripts/data migration plan and coordinating execution of the plans.

• Manage system operations such as change management processes for validated GxP systems, document all changes per internal controls, configure systems to align with business processes to meet the user requirements and update User Requirements and Configuration Specifications as needed

• Assess new features/release and provide impact assessment

• Manage various environments and migration of configurations from one environment to another

• Provide day-to-day administrative support for systems such as Veeva Vault – Quality Docs, LMS, CTMS, eTMF, RIM

• Triage and resolve issues reported by system owners and end users in the various GxP systems

• Provision new users, manage workflows, manage system configuration, for example:

• Configuration of users and groups, document types, properties, lifecycles and workflows, picklists, notifications, and security

• Bulk import/export of content and data

• Analysis and deployment of new features

· Perform other related duties as assigned from time to time based on company needs

QUALIFICATIONS

• 3+ years of direct experience with business analysis experience and demonstrable experience with computer systems validation within the Pharmaceutical/Biopharmaceutical/Medical Device industries

• 1+ years of experience as a systems administrator configuring workflows in Veeva vaults, such as QualityDoc, RIM, and eTMF, in life sciences industry is a must

• Familiar with 21 CFR Part 11 requirements and GAMP 5 guidance

• Familiar with systems such as ELN, LIMS, eDMS, LMS, RIM, eCTD, eTMF, CTMS, Pinnacle 21, SAS

• Certified Veeva System Administrator (White Belt)

• Bachelor’s degree or equivalent relevant experience

• Ability to quickly understand user requirements and needs and articulate potential solutions

• Hands on experience with administration of SaaS applications

• Experience with Single Sign on Technologies such as Okta is a plus

• Advanced technical and analytical skills

• Ability to work independently with minimal guidance in a fast-paced environment

• Excellent time management skills

• Good verbal and written communication skills

Company Description

Johnson Service Group, Inc. (JSG) is a leader in the staffing and consulting services industry, with over 35 years of experience investing in people and companies. We can be found locally in more than 30 offices throughout the United States and Canada and make connections throughout North America. JSG continues to work diligently to offer our clients and candidates world-class service and diversified offerings to fit their evolving needs. Which is why we have recently expanded our consulting services to include information technology consulting in addition to our wide array of staffing services. But don’t just trust us – let our accolades tell the story. For the past six years, JSG has been named to a variety of prominent Staffing Industry Analyst (SIA) award lists including: Largest U.S. Staffing Firms, Largest Canadian Staffing Firms, Fastest Growing U.S. Staffing Firms, and Largest U.S. Engineering Staffing Firms. People and culture make JSG a great place to work. We’re always looking for passionate and talented business development and recruiting professionals who want to build a future with one of our nationwide teams. We offer medical, dental, and life insurance options, sick time, 401(k) and more.