IT GxP Project Manager

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting‑edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, Docu Sign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real‑time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

We are seeking a strong Project Manager who has experience in a GxP regulated environment. The Project Manager will be responsible for managing SaaS, Cloud‑Based implementation and upgrade projects.

• Experience implementing SaaS, Cloud‑Based IT GxP applications, QMS, Track Wise Digital preferred but not mandatory.
• Create appropriate project plans and work schedules to meet business objectives and priorities.
• Provide an ongoing assessment and management of project risks and determine actions necessary to mitigate risks.
• Track and help resolve project issues.
• Execute and follow the Change Control process.
• Provide regular project plan updates and status reporting on financial and delivery progress.
• Lead project communications activities for owned work streams.
• Collaborate with other IT groups involved in the project delivery process.
• Assure, through monitoring and project oversight, project delivery is on‑time and within budget, identifying, tracking, reporting, and escalating issues as appropriate.

• Coordinate the delivery of training with business systems users and IT.
• Facilitate post‑implementation project reviews and the incorporation of learnings back into principles, policies, practices and the in‑house knowledge base.

• 5-15+ years’ experience.
• Hands‑on capability/experience leading large enterprise migrations or transformation in the Quality/Medical Device space.
• Previous project management experience on technical, IT, SaaS, Cloud‑Based projects.
• Demonstrated ability to think strategically when planning, managing teams and managing process.
• Skillful use of interpersonal skills and influence to ensure optimal team performance.
• Excellent communication skills which enable successful collaboration with senior level stakeholders.
• Strong experience facilitating project team meetings, cross‑functional communication and decision making, and ensuring alignment with business.
• Ability to work in a highly matrixed organization that is globally diverse.
• Extensive experience using MS Project, PowerPoint, Visio and MS Office Suite.
• Strong working knowledge of SDLC.
• Understanding of GMP systems and validation processes.

• University certificate or degree with a minimum of 5 years of related industry experience.
• Prefer PMI certification or comparable experience.

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.