Quality Control LIMS Project Manager-Contract

Company Description

Sia Partners is a next-generation consulting firm focused on delivering superior value and tangible results to its clients as they navigate the digital revolution. Our global footprint and expertise in more than 40 sectors and services allow us to enhance our clients’ businesses worldwide. We guide their projects and initiatives in strategy, business transformation, IT & digital strategy, and Data Science.

Job Description

We are working with a client in need of a qualified Quality Control Laboratory Information Management System Project Manager for an engagement opportunity at a leading local biologic life sciences company. This role is responsible for delivering project management support and oversight for the Veeva QMS and Veeva QDocs projects, with the finalization of the current ongoing QMS initiative followed by the implementation of Quality Docs, and any other projects as needed by the business in this space. This includes all work associated with the RFI and RFP processes, requirements definition, configuration, validation, cutover to production through hyper-care activities.

Project Length: 6 months+

Location: Remote (50%), On-site Philadelphia

Responsibilities

• Partner with stakeholders and Veeva COE Team to develop and execute the implementation plan.
• Manage constraints of schedule, budget and assigned resources to deliver defined scope.
• Oversees the development of GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance testing, traceability matrix, system, Validation Reports, SOPs, Change Control Documentation, and Risk assessment reports.
• Ensure that all proper documentation for GxP compliance is developed and delivered on time.
• Upload all project documentation to the project SharePoint site including required stage signoffs.
• Manage access permissions to the project SharePoint site.
• Manage budget, create budget review decks, and lead budget review with internal stakeholders.
• Work collaboratively with stakeholders to produce weekly project status reports.
• Create monthly steering committee presentations.
• Create change requests, update risk registers, decision logs, action logs, and meeting notes.
• Meet with IT Program Management and Portfolio Lead along with Veeva COE Team weekly to provide status updates.
• Ensure projects are executed on time, on budget and meet pre-established goals and objectives.
• Communicate system changes and issues to relevant stakeholders.
• Manage the delivery of any open defects, integration work, and/or requested enhancements post launch within the timeline established.
• Regularly interface with all levels of the organization and with external vendors. 

Qualifications

• Bachelor’s degree in Computer Science, Business Administration, or other related fields.
• 10+ years direct work experience in a project management capacity, including all aspects of process development and execution.7+ years in Life Sciences Quality Control experience including prior experience working in a GxP environment and implementing LIMS.
• Experience in implementing VEEVA Products.
• Strong familiarity with MS Project, JIRA, Microsoft Planner, and SharePoint.
• Experience in Agile PM methodology.
• PMP Certification is a plus.
• Life Sciences industry experience including prior experience implementing GXP systems.
• Experience in implementing Veeva Systems is a key and critical desirable.
• Strong experience working with SDLCs. 
• Strong written and oral communication skills.
• Strong interpersonal skills.
• Experience working independently and in team-oriented collaborative environments is essential.
• Flexible during times of change.
• Can conform and swiftly adjusts to shifting priorities, demands and timelines.
• Excellent analytical and problem-solving capabilities.
• Manages complex issues and risks and troubleshoots them as they arise.
• Able to handle multiple priorities and complex tasks in a dynamic work environment.
• Ability to work independently and with others in a widely disbursed, fast paced, team environment.

Additional Information

Our Commitment to Diversity

Diversity, equity, inclusion, and belonging (DEIB) are part of Sia Partners’ DNA. Thanks to our expertise in several sectors and our international growth, our teams include a variety of experiences and cultures. We’re confident that promoting DEIB creates an environment in which everyone can reach their full potential.

Our global network, DEIB@Sia Partners, brings together our people worldwide to fac