Sr. Project, Manager

Sunstar•Schaumburg, IL

About The Position

Project Management is an important interface function for developing innovative technologies and transferring them into new products and existing product portfolios of Sunstar product brands. The Project Manager facilitates joint product development activities among multidisciplinary teams. The Project Management Office supports the organization’s strategic objectives by sharing and standardizing project management resources, methodologies, tools, and techniques; providing guidance on accountability and results; supporting communication; and identifying gaps and opportunities. This role manages development projects for new products and product upgrades across the Americas and global projects involving drugs, medical devices, cosmetics, commodities, food, and food supplements. It works with project owners and cross-functional teams to assess user needs, establish plans, analyze expected benefits and risks, coordinate resources and budgets, and bring products to market within the agreed scope, quality, and timeline. The role also supports portfolio management, Design & Development audits and CAPA resolution, continuous improvement, project-management training, and project-management software deployment in the SAI region.

Requirements

Seven years of project-management experience in a regulated environment such as GMP, FDA, or cosmetic guidance.
Proven experience managing complex projects with several subprojects and/or many external partners.
Experience with Design Control and/or EN ISO 13485.

Nice To Haves

Preference for experience in drug or medical-device companies.
Experience compiling business cases and/or knowledge of financial aspects of product development.

Responsibilities

Plan, execute, and control development activities for new products and product upgrades, including formula-based, mechanical, biological, and surgical products, for Americas and global projects.
Evaluate user needs with project owners and translate them into development and project plans.
Analyze project proposals to assess expected benefits and minimize company risks.
Compile project plans, milestones, financial plans, and resource plans in collaboration with internal and external functions, suppliers, contract manufacturing organizations (CMOs), and partners.
Prepare projects for monthly IDC stage-gate meetings.
Organize and lead project and design review meetings, preparing statements and rationales to support decision-making, align objectives, and maintain timelines.
Manage project risks according to internal procedures, including follow-up to design reviews, and propose risk mitigations as needed.
Support Design & Development audit requirements by ensuring development work and documentation are inspection-ready and following internal procedures; serve as an interface among internal and external project team members.
Lead related CAPA resolution.
Provide portfolio analysis, strategic insights, risk assessments, and change-management guidance to drive business performance, with separate input for Innovation and life-cycle management portfolios.
Encourage collaboration and transparency across functions and regions, and support project-team engagement.
Continuously improve project-management processes and provide ad hoc training to improve organizational efficiency, quality, and time to market.
Make project management simple and accessible, and train the organization to remain accountable throughout the extended project life cycle, including after launch.
Lead deployment of Orchestra or other project-management software in the SAI region, provide training support, and identify maintenance needs.