Senior Project Manager – Global Regulated Products

Sunstar Americas, Inc; Schaumburg (IL); Sur place; USD 135 000 - 150 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Vision insurance

Dental insurance

401K with employer match

Résumé du poste

Sunstar Americas, Inc. is seeking an experienced Senior Project Manager to oversee development activities for cosmetics, pharmaceuticals, and medical devices across the Americas and globally.

You will translate user needs into rigorous plans, manage milestones, and coordinate with internal and external partners to ensure on-time, within-budget delivery. The role requires 7+ years in regulated PM, with Design Control/EN ISO 13485 experience, and a track record in complex programs with multiple

Qualifications

• Minimum 7 years in project management within GMP/FDA/cosmetic guidance environments.
• Experience with Design Control and EN ISO 13485 is required.
• Experience compiling business cases and understanding financial aspects of product development is advantageous.

Responsabilités

• Plan, execute, and control development activities for new products and upgrades across Americas and global projects.
• Translate user needs into development and project plans collaborating with sponsors.
• Prepare project plans with milestones, budgets, and resources across internal and external partners.
• Lead project and design review meetings and provide rationale for decisions.
• Manage project risk and CAPA resolution and support audits related to design & development.
• Provide portfolio analysis and risk assessments to drive business performance across Innovation and lifecycle management.
• Foster cross-functional collaboration across R&D, Marketing, QA, Manufacturing, and regulatory teams.
• Drive continuous improvement of PM processes and training across the organization.
• Lead deployment or upgrade of Orchestra or other PM software and provide training.

Connaissances

Project management

Regulatory awareness

Stakeholder coordination

Formation

7 years PM in regulated environment

Design Control / EN ISO 13485

Business case & financials knowledge

Outils

Orchestra PM software

Description du poste

Sunstar Americas, Inc. is seeking an experienced Senior Project Manager to oversee development activities for cosmetics, pharmaceuticals, and medical devices across the Americas and globally.

You will translate user needs into rigorous plans, manage milestones, and coordinate with internal and external partners to ensure on-time, within-budget delivery. The role requires 7+ years in regulated PM, with Design Control/EN ISO 13485 experience, and a track record in complex programs with multiple