SQA Solution
About the job Global Project Manager - CDx
Type : Contract, W2 only
Duration : 12+ months
Location : Tucson, AZ (hybrid - 2 days/week on-site)
Pay :
$
58/hr max,
DOE, all-inclusive
Please note that at this time we are unable to sponsor employment authorization (both new and transfer)
Description:
The Global Project Manager (GPM) plays a key role in optimized product delivery, accountable for all project management aspects of various projects from simple to complex in nature. Drives the project/product from the original concept through completion by developing and directing detailed work plans, schedules, project estimates, spending, resource plans, and status reports. As a trusted advisor, the GPM translates and drives projects into products and enables the organization to use energy and time effectively and efficiently while quickly responding to changing business needs across the portfolio.
Responsibilities:
Drive the delivery of innovative Companion Diagnostics projects, working with both internal project stakeholders as well as external Pharma partners. Own project/program/product structures for product development and product care activities, including communication management, timelines, resource and budget plans, progress, and cost control. Create, coordinate, and maintain integrated project plans, including dependencies, resources, and budgets, allowing teams to work efficiently and effectively. Be accountable for quality implementation in complex projects in the following areas: project risk management, critical path analysis, scenario creation and analysis, budget analysis, and robust planning. Proactively identify gaps, potential bottlenecks or delays, challenge assumptions, and propose innovative options to close gaps and get complex projects back on track while communicating issues proactively to stakeholders. Consistently execute project management processes, including guiding and managing preparation for milestone reviews, capacity reviews (cQCR, SCR & fQCR), etc., as applicable, and may lead improvement initiatives. Select project methodology and apply Agile methods as appropriate, including coaching and guiding teams in project methodology, including Agile practices (with Project/Program Leads or PMC management if appropriate). Lead meetings and foster knowledge sharing between project/product teams to enhance project effectiveness and optimized delivery. Establish, measure and report Key Performance Indicators (KPIs), standard metrics, Objectives and Key Results (OKRs) or Outcome Based Planning (OBPs) key results for projects, enabling teams and functions to measure and improve quality, efficiency, and effectiveness. Act as a trusted advisor with a 360° view on all levels to advise and support the project/product teams as well as the broader organization in holistic planning, project risk management, scenario creation as well as critical path analysis, with the aim to ensure optimized value delivery. Be the single point of contact and control for project and program data collected from the functions. Act as Agile Program Manager as defined by Scaled Agile Framework (SAFe) where applicable. Requirements:
Bachelor's degree in science, engineering or business related fields. 4+ years of project management experience in the diagnostic, medical device, health science, pharmaceutical or biotech industry leading complex new, product development and product care projects. Project management experience in other regulated industries will also be considered. Demonstrated experience using Planisware, MS-Office, G-Suite and know-how of project management tools such as Trello, LucidChart, Smartsheet, Jira, Azure DevOps, etc. 1+ year of experience in clinical biomarker or In Vitro Diagnostic development, companion diagnostic development, analytical and clinical validations and regulatory submissions or instrument development and program management. 1+ year of experience in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001) Experience driving the delivery of high-complex product development projects, from conceptualization to commercialization. Knowledge of relevant Design Control and/or Phased Development processes. Knowledge of healthcare quality, risk, and/or regulatory compliance. PMP Certification and SAFe Certification (preferred).
We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs
Type : Contract, W2 only
Duration : 12+ months
Location : Tucson, AZ (hybrid - 2 days/week on-site)
Pay :
$
58/hr max,
DOE, all-inclusive
Please note that at this time we are unable to sponsor employment authorization (both new and transfer)
Description:
The Global Project Manager (GPM) plays a key role in optimized product delivery, accountable for all project management aspects of various projects from simple to complex in nature. Drives the project/product from the original concept through completion by developing and directing detailed work plans, schedules, project estimates, spending, resource plans, and status reports. As a trusted advisor, the GPM translates and drives projects into products and enables the organization to use energy and time effectively and efficiently while quickly responding to changing business needs across the portfolio.
Responsibilities:
Drive the delivery of innovative Companion Diagnostics projects, working with both internal project stakeholders as well as external Pharma partners. Own project/program/product structures for product development and product care activities, including communication management, timelines, resource and budget plans, progress, and cost control. Create, coordinate, and maintain integrated project plans, including dependencies, resources, and budgets, allowing teams to work efficiently and effectively. Be accountable for quality implementation in complex projects in the following areas: project risk management, critical path analysis, scenario creation and analysis, budget analysis, and robust planning. Proactively identify gaps, potential bottlenecks or delays, challenge assumptions, and propose innovative options to close gaps and get complex projects back on track while communicating issues proactively to stakeholders. Consistently execute project management processes, including guiding and managing preparation for milestone reviews, capacity reviews (cQCR, SCR & fQCR), etc., as applicable, and may lead improvement initiatives. Select project methodology and apply Agile methods as appropriate, including coaching and guiding teams in project methodology, including Agile practices (with Project/Program Leads or PMC management if appropriate). Lead meetings and foster knowledge sharing between project/product teams to enhance project effectiveness and optimized delivery. Establish, measure and report Key Performance Indicators (KPIs), standard metrics, Objectives and Key Results (OKRs) or Outcome Based Planning (OBPs) key results for projects, enabling teams and functions to measure and improve quality, efficiency, and effectiveness. Act as a trusted advisor with a 360° view on all levels to advise and support the project/product teams as well as the broader organization in holistic planning, project risk management, scenario creation as well as critical path analysis, with the aim to ensure optimized value delivery. Be the single point of contact and control for project and program data collected from the functions. Act as Agile Program Manager as defined by Scaled Agile Framework (SAFe) where applicable. Requirements:
Bachelor's degree in science, engineering or business related fields. 4+ years of project management experience in the diagnostic, medical device, health science, pharmaceutical or biotech industry leading complex new, product development and product care projects. Project management experience in other regulated industries will also be considered. Demonstrated experience using Planisware, MS-Office, G-Suite and know-how of project management tools such as Trello, LucidChart, Smartsheet, Jira, Azure DevOps, etc. 1+ year of experience in clinical biomarker or In Vitro Diagnostic development, companion diagnostic development, analytical and clinical validations and regulatory submissions or instrument development and program management. 1+ year of experience in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001) Experience driving the delivery of high-complex product development projects, from conceptualization to commercialization. Knowledge of relevant Design Control and/or Phased Development processes. Knowledge of healthcare quality, risk, and/or regulatory compliance. PMP Certification and SAFe Certification (preferred).
We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs