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Lead Program Integrator – REMOTE (JP9390)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Lead Program Integrator – REMOTE (JP9390)
Location: Thousand Oaks, CA. (100% REMOTE)
Employment Type:  Contract
Business Unit: Final Product Technologies Development Product Engineering
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 11/1/21


3 Key Consulting is hiring a Lead Program Integrator for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Medical device and/or combination product development experience; design controls experience.  Description:
  • Responsible for overall coordination, status reporting, and stability of Core Team project activities. Manages one or more cross-functional projects of medium to high complexity.
  • Establishes and implements project management processes and methodologies to support the various program Core Teams, including subteams within the FPT function, to ensure projects deliverables are completed on time and adhere to high quality standards.
  • Responsible for creating and owning project plans and teamwork assignments for technical projects, directing and monitoring work efforts on a daily basis, identifying resource needs; and escalating functional, quality, timeline issues appropriately.
  • Responsible for tracking key project milestones and adjusting project plans to meet milestones on time.
  • Coordinates communication with Core Team, Core Team Leads and across process development sub-functions to drive completion of technical program activities.
  • Assists Program Manager(s) and team leads as a partner to communicate risks to project timeline; partners to escalate and actively resolve issues.
  • Must possess extensive knowledge and expertise in the use of project management methodologies and tools, as well as technical expertise in Combination Product development and Design Controls.
  • The Lead Program Integrator (LPI) is responsible for driving program execution of various medium to small projects.
  • This role leads across the project Core Team(s) supporting the technical lead.
  • Individual works with the Program Managers and Project Leaders to ensure that the necessary skills and resources are effectively applied and delivering to plan.

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:
  • Engineering related degree.
  • Medical device or combination product experience required.
  • Project management experience.

Day to Day Responsibilities:
  • Responsible for overall coordination, status reporting, and stability of Core Team project activities. Manages one or more cross-functional projects of medium to high complexity. Establishes and implements project management processes and methodologies to support the various program Core Teams, including subteams within the FPT function, to ensure projects deliverables are completed on time and adhere to high quality standards.
  • Responsible for creating and owning project plans and teamwork assignments for technical projects, directing and monitoring work efforts on a daily basis, identifying resource needs; and escalating functional, quality, timeline issues appropriately. Responsible for tracking key project milestones and adjusting project plans to meet milestones on time.
  • Coordinates communication with Core Team, Core Team Leads and across process development sub-functions to drive completion of technical program activities. Assists Program Manager(s) and team leads as a partner to communicate risks to project timeline; partners to escalate and actively resolve issues. Must possess extensive knowledge and expertise in the use of project management methodologies and tools, as well as technical expertise in Combination Product development and Design Controls.
  • The Lead Program Integrator (LPI) is responsible for driving program execution of various medium to small projects. This role leads across the project Core Team(s) supporting the technical lead. Individual works with the Program Managers and Project Leaders to ensure that the necessary skills and resources are effectively applied and delivering to plan.

Essential Responsibilities :
  • Lead medium/small projects independently and work directly with Program Manager on large multi-year programs.
  • Partners with technical lead to manage day to day program activities. Owns, creates and maintains a detailed project activities list and tracking tools, identifying and mitigating risks to completing program deliverables, driving program task execution, and attending regular core team meetings to gather and maintain status updates on critical path deliverables owned by the Core Team.
  • Ensures that the product development process abides by all defined cross-functional standards, meets the intent and letter of SOPs and all compliance and regulatory needs of the applicable markets.
  • Co-Leads the cross-functional Program Core Team to establish an integrated plan for resources and materials to deliver the new product program per the Product Delivery Team commitment.
  • Identifies issues early and solves complex and ambiguous cross-functional integration problems leading the team to deliver per Product team commitments including completing goals, execution adjustments/iterations, and cross-functional teamwork.
  • Works with the system, subsystem/platform, supply chain, service, QA, RA, Research project leaders to deliver quality products on time, within budget, and with the necessary features/functionality.
  • Works with the functional engineering leadership team to grow project leadership skills within the Core Team

Basic Qualifications:
  • Bachelor's / Master's Degree in Electrical/Mechanical /Biomedical Engineering Computer Engineering or equivalent experience
  • Medical device and/or combination product development experience; design controls experience
  • 4+ years' experience in project leadership in engineering product development, manufacturing or research environment, including previous leadership of a global and/or virtual team.
  • 5+ years of more progressive responsibility and experience as an engineer or scientist
  • Demonstrated ability to build lasting cross-functional relationships, including strong influential and communication skills
  • Demonstrated understanding/experience with the New Product Introduction (NPI) cycle and cross-functional interdependencies
  • MS Project, One Pager, MS Teams, Smartsheet experience a plus

Employee Value Proposition:
You will be responsible for project management.

Red Flags:
  • No Medical device/ Combination product experience.
  • No project management.
  • No engineering background.
  • Poor presentation skills.

Interview process:
Video Skype Panel Interview.


We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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