Global Project Manager- Companion Diagnostics

Software Guidance & Assistance, Inc., (SGA), is searching for a Global Project Manager- Companion Diagnostics for a CONTRACT assignment with one of our premier Pharmaceutical Services clients in Tucson, AZ.

Responsibilities:
As part of the Project Management Chapter (PMC), 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.

• You will drive the delivery of innovative Companion Diagnostics projects, working with both internal project stakeholders as well as external Pharma partners.
• You will own project/program/product structures for product development and product care activities, including communication management, timelines, resource and budget plans, progress, and cost control. You will create, coordinate, and maintain integrated project plans, including dependencies, resources, and budgets, allowing your teams to work efficiently and effectively. You will 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.
• You will identify project risks and describe potential implications for budget, timeline, and scope. You will 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.
• You will 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. You will implement 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 lead meetings and foster knowledge sharing between project/product teams to enhance project effectiveness and optimized delivery.
• You will 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.
• 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 holistic planning, project risk management, scenario creation as well as critical path analysis, with the aim to ensure optimized value delivery. You will be the single point of contact and control for project and program data collected from the functions.
• You will manage project/product team information to support your teams themselves, the Life Cycle Teams (LCTs), and/or other governing body decision-making. Frequently, you will provide high-level, pre-defined and recent planning data for scenario analysis and decision-making on a portfolio level. You will act as Agile Program Manager as defined by Scaled Agile Framework (SAFe) where applicable.

Required Skills:

• Bachelor's degree (from an accredited institution) in science, engineering, or business-related fields
• 4+ years 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.
• 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 using Planisware, MS-Office, G-Suite, and "know-how" of project management tools such as Trello, LucidChart, Smartsheet, Jira, Azure DevOps, etc.
• Profound problem-solving skills and critical thinking with the ability to synthesize information to identify relevant insights that will advise improvement opportunities
• You have a reputation for proactively and successfully driving the delivery of high-complex product development projects, from conceptualization to commercialization.
• Interpersonal and influencing skills with an established ability to drive decisions; you have demonstrated ability to identify, facilitate and communicate issues proactively to a wide range of stakeholders
• Communication skills (both verbal and written) and presentation skills to enable effective cross-functional collaboration
• Understanding and knowledge of relevant Design Control and/or Phased Development processes
• Understanding and knowledge of healthcare quality, risk, and/or regulatory compliance
• Good strategic and tactical thinking, and profound analytical thinking.
• Escalate and drive management decisions in relation to project execution and resource needs.
• You have a value delivery mindset.

Preferred Skills:

• Master's degree (from an accredited institution) in science, engineering, or business-related fields
• Experience with Agile development practices and mindset
• PMP Certification as well as SAFe Certification

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy.

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