This is Srikanth from Reliable Software. We have an opportunity with one of our direct clients, and I'd like to share the details with you. Please review the information below and let me know if you're interested. Kindly share your updated resume if you'd like to be considered.
Job Title: Global Project Manager with Healthcare
Location: Tucson, AZ
Long-term contract
This role requires a Global Project Manager with life science /pharma experience
Candidates must have 4+ years of hands-on project management experience leading end-to-end product development or product care projects in a regulated environment (FDA 21 CFR Part 820, ISO 13485/9001).
Mandatory experience includes exposure to analytical or clinical validation, regulatory submissions, clinical biomarkers, instrument/system development, or CDx programs.
The candidate must be comfortable working in a hybrid Agile model, combining Agile/SAFe practices within teams and traditional stage-gate methods with external partners.
Relocation assistance is not available for this job posting. This is a hybrid position with an expectation of on-site presence in the Oro Valley, AZ campus ~2 days/week.
As part of the Project Management Chapter, the Global Project Manager (GPM) plays a key role in optimized product delivery and is 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 Global Project Manager 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.
The Opportunity:
You will own project/program/product structures for Companion Diagnostics (CDx) product development & product care activities including communication management, timelines, resource and budget plans, progress and cost control, and risk management.
You will create, coordinate, and maintain integrated project plans including dependencies, resources and budgets, allowing the teams to work efficiently and effectively. You are accountable for quality implementation in projects in the following areas: Project risk management; Critical path analysis; Scenario creation and analysis; Budget; Robust planning.
You will proactively own and drive integrated project plans including dependencies, resources and budgets allowing the teams to work efficiently and effectively.
You will execute project management processes including guiding and managing preparation for milestone reviews, capacity reviews (cQCR, SCR & fQCR), etc., as applicable & may lead improvement initiatives. You will follow best practices in project/product teams and foster continuous improvement by sharing best practices and knowledge among peers.
You will 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). You have expertise in working in a hybrid Agile role, combining Agile methods (usually within the project/product team) with non-Agile techniques (usually needed with partners and some functions).
You will establish, measure, and report the 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.
You will 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 the holistic planning; project risk management; scenario creation as well as critical path analysis with the aim to ensure an optimized value delivery. You will serve as a single point of contact & control for project and program data collected from the functions.
You will lead project team meetings and foster knowledge sharing between project/product teams and sub-chapters to enhance project effectiveness and optimized delivery.
You will identify project risks and describe potential implications for budget, timeline and scope. You will identify gaps, potential bottlenecks or delays, challenge assumptions and propose options to close gaps and get projects back on track while communicating issues proactively to stakeholders.
You will manage project/product team information to support the teams themselves, the Life Cycle Teams (LCTs) and/or other governing body decision making. Frequently provides high level/pre-defined and recent planning data for scenario analysis and decision making on a portfolio level. You will serve as an Agile Program Manager as defined by Scaled Agile Framework (SAFe) where applicable.
Other duties as assigned by leadership
Primary skill set:
You hold a Bachelor’s degree, preferably in a Life Sciences field.
You have 4 years of experience in project management / engineering/ business in the diagnostic, medical device, pharmaceutical or biotech industry leading product development and product care projects.
You have at least one year of experience in the following areas: clinical biomarker or In Vitro Diagnostic development, companion diagnostic development, analytical and clinical validations, regulatory submissions, instrument/systems development, or program management)
You have one year of experience in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001).
Educational Qualifications:
- Required - Bachelor’s degree in Computer Science, Information Technology, Computer Engineering or closely related or equivalent.
- Preferred - Master’s degree in Management Information Systems (MIS), Computer Science, Big Data or Analytics or equivalent.
Travel:
· Open to travel based up on the nature of the engagement.
Thanks & Regards
Srikanth Donkani
Sr. Talent Acquisition Specialist
(w):
(E):
2260 Haggerty Road, Suite 285 Northville, MI 48167
Equal Employment Opportunity
Reliable Software employment does not discriminate on the basis of race, religion, gender, sexual orientation, age or any other basis as covered by federal, state, or local law.
Employment decisions are based solely on qualifications, merit and business needs.
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