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Sr. Program Manager
NPAworldwide Recruitment Network
NPAworldwide Recruitment Network
 
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Job Location: , California - United States
JOB DESCRIPTION

Job #: 44810
Title: Sr. Program Manager
Job Location: California - United States
Remote Job: Unknown
Employment Type:
Salary: contact recruiter for details
Other Compensation: Bonus
Employer Will Recruit From: Regional
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?

We have recently been engaged by a Tier 1; Global publicly traded company that is a world leader in the areas of life sciences, industrial and applied Sciences, clinical Diagnostics and overall lab solutions. The division we are working for is their state of the art Niche Diagnostics Program management office.

As they continue to grow at record setting levels they require a Senior Program Manager. The Candidate they seek will be an industry veteran who has lead multiple new product development projects from concept through to commercial launch utilizing critical path techniques and proven PMP philosophies. This will be an industry professional that has lead complex and virtual cross-functional project teams from feasibility to launch, is working in a FDA regulated environment, and brings advanced understating of design control standards and regulatory compliance. The successful Candidate will also bring a healthy mix of technology knowledge and business acumen with experience using financial tools and has managed large project budgets while collaborating with multiple departments

JOB DESCRIPTION

Job Title: Sr Program Manager - Remote an Option

Remote in CA. for qualified candidate Clinical Diagnostics

The Niche Diagnostics Program Management Office (PMO) is seeking a Senior Program/Project Manager who will manage complex New Product Development projects to successful and timely commercial launch. This role will lead cross-functional new product development teams for In Vitro Diagnostics (IVD) devices in accordance to FDA, ISO 13485, and international regulations, as well as company Design Control procedures and phase gate approval processes.

The role will also support RUO products, sustaining projects, and PMO departmental initiatives. What will you do?

  • Create and maintain project timelines ensuring project tasks, dependencies and responsibilities are well defined. Utilize critical path techniques in schedule development and project monitoring.
  • Establish and manage project budgets in collaboration with Finance and cross-functional departments. Ensure contractual obligations and financial milestones are met.
  • Estimate resource requirements over the course of the project and work with management to address resource constraint issues.
  • Facilitate the completion of various design control documents (project plans, design inputs, design outputs, risk, etc) and maintain design history files to ensure adherence to quality procedures.
  • Identify, document, and mitigate project risks and contingency plans.
  • Collaborate with OEM partners to ensure coordination of timelines, identify critical milestones, risk mitigation, and communication of progress.
  • Lead project team meetings, drive team decisions, and ensure alignment with internal and external partners.
  • Manage scope creep and ensure customer, team, and company needs are met.
  • Promote a proactive, positive and professional culture within the Program Management Office. Mentor and coach junior Project Managers.
  • Contribute to continuous improvement of PMO processes, related SOPs, and supporting tools.

How will you get there? Education/Experience:

  • Bachelors degree in life sciences, engineering, or equivalent. PMP (Project Management Professional) certification strongly recommended
  • 10 years industry experience; 5+ years in Project Management roles with increasing responsibilities.
  • Experience working in an FDA regulated environment is required.
  • Advanced understanding of design control quality standards and regulatory compliance requirements for medical device or diagnostics (ex. 510K submissions). Experience in developing Therapeutic Drug Monitoring (TDMs) Tests, Infectious Disease Tests, Toxicology Tests, QC Controls, or Companion Diagnostic test is preferred.
  • Strong understanding of product development challenges and methods for resolution. High-level business acumen with experience using financial tools.
  • Demonstrated skills using MS Project or related software for Project Management. Solid skills using MS Office, Outlook, Smartsheets, PPM Pro or other project management software. Non-Negotiable Hiring Criteria:
  • Solid ability to lead complex and virtual cross-functional project teams from feasibility to launch.
  • Outstanding organizational skills with ability to multi-task and balance sophisticated and routine work activities.
  • Demonstrated ability to lead, direct and manage cross-functional teams, influence business partners and get results through others. Strong conflict resolution skills.
  • Excellent written and verbal communication skills with the ability to effectively communicate with team members, functional management and senior leadership
QUALIFICATIONS

  • Bachelors degree in life sciences, engineering, or equivalent. PMP (Project Management Professional) certification strongly recommended
  • 10 years industry experience; 5+ years in Project Management roles with increasing responsibilities.
  • Experience working in an FDA regulated environment is required.
  • Advanced understanding of design control quality standards and regulatory compliance requirements for medical device or diagnostics (ex. 510K submissions). Experience in developing Therapeutic Drug Monitoring (TDMs) Tests, Infectious Disease Tests, Toxicology Tests, QC Controls, or Companion Diagnostic test is preferred.
  • Strong understanding of product development challenges and methods for resolution. High-level business acumen with experience using financial tools.
  • Demonstrated skills using MS Project or related software for Project Management. Solid skills using MS Office, Outlook, Smartsheets, PPM Pro or other project management software. Non-Negotiable Hiring Criteria:
  • Solid ability to lead complex and virtual cross-functional project teams from feasibility to launch.
  • Outstanding organizational skills with ability to multi-task and balance sophisticated and routine work activities.
  • Demonstrated ability to lead, direct and manage cross-functional teams, influence business partners and get results through others. Strong conflict resolution skills.
  • Excellent written and verbal communication skills with the ability to effectively communicate with team members, functional management and senior leadership

Education:
University - Bachelor`s Degree/3-4 Year Degree




How to Apply:


 

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