Sr. Project, Manager

Sunstar Americas, Inc; Schaumburg (IL); On-site; USD 135,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

Dental insurance

401K with employer match

Job summary

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.

Responsibilities

• 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.

Skills

Project management

Regulatory awareness

Stakeholder coordination

Education

7 years PM in regulated environment

Design Control / EN ISO 13485

Business case & financials knowledge

Tools

Orchestra PM software

Job description

Project Management is an important interface function for developing innovative technologies and for transferring them into new products and existing product portfolios of the Sunstar product brands and thus, for serving our customers and patients, respectively in an optimal way and with a smart and sufficiently broad product portfolio. The project manager facilitates the joint product development activities of the multi-disciplinary project teams.

The Project Management Office (PMO) supports the organization strategic objectives by facilitating the sharing and standardization of project management resources, methodologies, tools, and techniques. It aims at providing guidance on accountability and results, on supporting communication and identifying gaps and opportunities.

Job Responsibilities:

• Project Management by planning, executing, and controlling of development activities for new products, and product upgrades (Formula-based, mechanical, biological, and surgical products) for Americas regions as well as for Global projects focusing on drugs and/or medical devices and/or cosmetics/commodities/food and food supplement.
• Evaluation of user needs in collaboration with the project owner for new product developments and transferring the user needs into a development and project plan. Analyze project propositions to ensure it will deliver expected benefits with minimum risks for the company. The sponsor is typically SESA marketing, or could be occasionally cross regional with SAI or SSJ or another function.
• Compilation of projects plans with milestones, financial and resource planning based upon feedback and intense, direct collaboration with all internal and external functions including suppliers, CMOs and any relevant partner to achieve the shortest possible time to market for launching new products as per desired scope, quality and within the agreed budget. Ensure all project are ready to be presented to monthly IDC meeting (stage-gate process).
• Organizing and leading project and/or design review meetings also by preparing statements and rationales for decision making by the project teams to align project objectives and for keeping the project timelines
• Project risk management by following internal procedures also as a follow-up activity for design reviews and for proposing risk mitigations if needed
• Support and manage all audit requirements related to Design & Development by ensuring the development and documentation quality is ready for being inspected by following internal procedures and by working as an interface with all 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. Input should be provided on separate portfolio for Innovation and life cycle management projects.
• Encourage, support collaboration and transparency across functions (R&D; Mktg; Proc; RA; QA: Manufacturing; F&A etc) and across regions. Support project team engagement (purpose, passion, and dedication).
• Provide continuous improvement of internal project management related processes and ad-hoc trainings to reinforce organization skills for enhanced efficiency, quality and time to market. Work on making project management simple and accessible. Strive to train the organization to become accountable on extended project life cycle (i.e., after launch).
• Lead Orchestra or other project management software deployment at SAI region, provide training support and identify maintenance needs.

Education:

• 7 years in project management in a regulated environment like GMP, FDA, cosmetic guidance, with preference on drugs, medical device companies as well as proven experience in managing complex projects with several sub-projects and/or many external partners
• Experience with Design Control and/or EN ISO 13485 required
• Compilation of business cases and/or knowledge in financial aspects of product development advantageous.

What Makes Sunstar Special is:

• A business focused on health and wellness of people around the world
• High Quality Products
• Beautiful state-of-the-art facility
• Diversity and Inclusion
• Corporate Social Responsibility Program and partnership with charitable organization
• Strong value placed on company culture
• Excellent, comprehensive insurance coverage that includes Medical, Vision, and Dental benefits.
• Opportunities for career growth and advancement
• Employee discount on Sunstar products
• 401K retirement plan with employer match (Pretax and Roth options)
• 401K profit sharing contribution based on company performance.
• Paid holidays and generous paid time off.Pet, Legal and Identity Theft Insurance Plans
• Competitive bonus
• On Site Fitness Center
• Corporate Perks Discount Program (Auto, Retail, Electronics, Entertainment, Computers, Personal Vacations, Cell Phones, Movie Tickets, Eating Out and Much More)
• Holiday Lunches
• Beautifully maintained walking trails
• Nuneous employee appreciation events throughout the year.
• Recognition and Rewards Programs
• Anniversary, Birthday and New Hire Announcements

If you'd enjoy a career helping others attain overall health through oral health, consider joining the Sunstar Americas, Inc. team.

The employer is subject to certain governmental record keeping and reporting requirements for the administration of civil rights laws and regulations. In order to comply with these laws, the employer invites employees to voluntarily self-identify their gender, and race or ethnicity. Completion of this data is voluntary and will not affect your opportunity for employment or terms or conditions of employment. Information collected will be used for EEO-1 reporting purposes only and will be kept separate from all other personnel records, only accessed by Authorized Users. Information collected will be kept confidential and will only be used in accordance with the provisions of applicable laws, including those that require the information to be summarized and reported to the federal government. When reported, data will not identify any specific individual.

The pay range for this position of Sr. Project Manager is $135,000- $150,000. However, base pay offered may vary depending on skills, experience, job-related knowledge and location. This position is also eligible for an annual bonus as part of total compensation.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.