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Sr. Project Manager – GmP Systems

Employer
DigitalRadius
Location
Working from home
Start date
Aug 8, 2022
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Position Summary:

The IT Sr. Project Manager GmP Systems is responsible for the definition and delivery of one or more GmP Systems projects associated with Biopharma manufacturing build-out, driving Digital Transformation for DigitalRadius Clients in the fast-paced & dynamic Life Sciences sector. 

Company Summary:

DigitalRadius partners with innovative organizations by guiding them through Digital Transformation to achieve seamless integration, enable successful business outcomes across the entire enterprise, and expedites patient therapies.  The DigitalRadius staff blends our extensive industry experiences and know-how in delivering solutions through partnership efficiently and effectively.  DigitalRadius is well funded, scaling rapidly and has numerous contracts with revolutionary BioPharma, and Life Sciences companies that are advancing human healthcare. 

DigitalRadius is expanding Digital Transformation ideals, helping clients create a fully integrated digital backbone in the Life Sciences Sector.  Ander Tallett, Founder and CEO started the company in 2020 following 5 years at Moderna where he was the VP Enterprise Systems and his team was recognized with several awards including the SAP Innovation Award, ISPE Facility of the Future, AWS, and Boomi recognition. 

This is a very unique opportunity to work with an innovative company that is leading Digital Transformation across multiple industries which directly improves patient outcomes.

Areas of Responsibility: 

  • Define and lead complex GmP Systems projects which deliver tangible benefits to the Client, meet security, quality, time and financial constraints and delivers in accordance with the client’s specification.
  • Create, or ensure the creation of, required SDLC and Project Documentation as defined by the client requirements, such as Project Charter, Project or Data Migration Plan, Risk/Issue/Decision log.
  • Manage project teams for clients which may involve internal staff, external partners, and vendors in a collaborative, inclusive and positive manner.
  • Develop strong relationships with key business stakeholders.
  • Ensure IT project plans are aligned with the business expectations.
  • Produce and deliver against the agreed project plans and key milestones.
  • Responsible for the effective operation of the IT Request for Change process.
  • Close, effective collaboration with Systems Architect, Support Teams, and other client Sr IT management as needed.
  • Provide functional expertise where appropriate.
  • Lead, train, mentor and coach the Project team ensuring people development, staff and key skill retention and knowledge management.
  • Create process maps and identify areas of optimization for IT workflows where appropriate.

Other Skills and Abilities:

  • Experience working on GmP IT system selection, implementation and/or upgrade supporting the build-out of Biopharma manufacturing capabilities. Examples include systems and processes supporting batch manufacturing, integration with ERP, and facilities monitoring systems.
  • Demonstrated track record managing the implementation of systems or process in SaaS methodology.
  • Ability to operate and deliver multiple projects in a fast-paced, unstructured environment.
  • Ability to effectively collaborate in a dynamic environment.
  • Excellent organization and time management skills.
  • Skilled at risk and issue management.
  • Effectively delegate and manage task assignment to project team members in a matrix environment.
  • Demonstrable financial control of project budgets.
  • Highly organized individual capable of defining project and driving though to delivery against defined plan.
  • Willing and able to challenge effectively to ensure that deliverables are reflective of the wider needs.
  • Experience with leading Digital Transformation or business change programs a big plus.
  • Experience in developing and coaching other PM’s in establishing project delivery structure a plus.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required. 

Education/Experience: 

  • Experience at managing multi-discipline projects which include both business and technical resource from initial inception through to delivery and benefits realisation in accordance with regulatory requirements.
  • Experience of managing a portfolio of projects to required deadlines, quality and cost.
  • Bachelor's degree in engineering, technology, life sciences or other relevant discipline.
  • 10+ years of work experience in functional or cross functional roles.
  • Knowledge of Biopharmaceutical R&D IT Systems, with a focus on Clinical Development systems.
  • Project Management Certification is a plus.
  • MBA or an advanced university degree or professional qualification a plus.
  • Program Management Certification is a plus.
  • Line Management experience is a plus.

Reasoning Abilities:

  • Effective written and verbal communication skills
  • Effective presentation skills
  • Able to engage at all levels of the organization while operating under pressure to meet tight deadlines

 

Computer Skills:

  • Relevant project management and communication tools such as MS Project, Jira, Confluence, SmartSheet.
  • Relevant office productivity tools, such as Microsoft suite (Outlook, Word, Excel, PowerPoint or Google office Productivity tools, such as gmail, google calendar.
  • Relevant workflow and drawing tools, such as Viso, Lucidchart, SmartSheet.

 

Safety/Personal Protective Equipment (PPE):

Adhere to company and client safety policy, vaccines policy and PPE policy.

Our Mission:

Guiding organizations through Digital Transformation to achieve seamless integration, enable successful business outcomes, that expedites patient therapies.

DigitalRadius is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. DigitalRadius will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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