Global Project Manager- Personalized Healthcare Solutions

SGS Consulting; Yuma (AZ); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

SGS Consulting seeks a seasoned Project Manager to lead Companion Diagnostics (CDx) development and product care programs. You will own structures, dependencies, budgets, and milestones, and you will drive integrated plans for efficient delivery across cross-functional teams.

You will apply agile methods in a hybrid setup, establish KPIs/OKRs, mentor teams, and act as a trusted advisor for holistic planning and risk management across projects.

Qualifikationen

• 4 years of experience in project management / engineering / business in diagnostic, medical device, pharmaceutical or biotech industries.
• At least one year in clinical biomarker or In Vitro Diagnostic development or companion diagnostics, validations, regulatory submissions, instrument/systems development or program management.
• At least one year in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001).

Aufgaben

• You will own project/program/product structures for CDx development and care activities including communications, timelines, resources and budget plans.
• You will create and maintain integrated plans with dependencies, resources and budgets, enabling teams to work efficiently.
• You will drive integrated project plans, improving quality, efficiency and delivery.
• You will guide project management processes for milestone / capacity reviews and drive improvement initiatives.
• You will apply agile methods as appropriate, coaching teams in agile practices in hybrid roles.
• You will establish and report KPIs/OKRs/OBPs to measure and improve outcomes.
• You will act as trusted advisor and single point of contact for project data and planning.
• You will lead project team meetings and promote knowledge sharing across teams.
• You will identify risks and gaps, and propose options to keep projects on track while communicating issues to stakeholders.
• You will support life cycle teams and decision making with planning data for portfolio level reviews.
• You will serve as an Agile Program Manager per SAFe where applicable.
• Other duties as assigned by leadership.

Kenntnisse

Project management

Agile practices

Biotech/diagnostic industry experience

Jobbeschreibung

Job Responsibilities:

• 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.

Skills:

• 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).

Education/Experience:

• 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).