Senior Manager, Quality Systems, Product Development - Pharma (Remote)

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

The Sr. Manager, Quality Systems, Product Development is responsible for the strategic leadership of the Product Development and Lifecycle Management Quality System including creation, architecture, implementation, and continuous improvement of the global process for all Baxter products including: Pharmaceuticals (therapeutics, solutions, and generic drugs), Biologic Products, Medical Devices (electromechanical and disposables), and Software as a Medical Device. This is an individual contributor position.

This role identifies and drives continuous improvements to the product lifecycle management system while building and managing relationships with the Global Business Units including R&D, Global Supply Chain, Supplier Quality Management, Post-Market Surveillance, Worldwide Medical, Marketing, and Regulatory Affairs to ensure alignment on strategic initiatives.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What you'll be doing:

• Serves as one of the senior technical representatives in Product Development and Lifecyle Management (PDLM) in the Quality organization with responsibility for process results in terms of product quality, performance, and safety.
• Manages interface with Quality Compliance audit team to support audit plans, due diligence plans, and inspection readiness plans. Provides support for internal audits and external inspections.
• Develops new and improved processes in collaboration with other QMS element Stewards and global leadership. Influences the decision-making process to ensure quality requirements are included when improvement initiatives take place.
• Provides quality systems support for all products including: Electromechanical, Disposables, Containers, Implantable Devices, Biologic Devices, Therapeutics, and Software products. Includes all lifecycle phases from late-stage feasibility through development, sustaining, and discontinuation.
• Serves as the data architect for implementation for Product Lifecycle Management (PLM) systems to ensure product information and where used here reporting requirements are met.
• Interacts frequently with plants, R&D, RA, Labeling and other internal supervisors, functional peer and senior leaders also leads interactions with regulators and customers to represent the company products and processes.
• Identifies and leads continuous improvement projects with the objective of achieving quality, reliability, and cost improvements.
• Flexibility to travel up to 20% both international and domestic.
   

What you'll bring:

• BS in science or engineering; advanced degree helpful.
• 7 years in Quality, Manufacturing, Engineering or related field.
• Thorough knowledge of Product Development and Change Control , regulations and standards.
• Certified Manager of Quality/Organizational Excellence, Quality Engineer, Lead Auditor, or Six Sigma, is preferred.
• Demonstrated knowledge and experience in a pharmaceutical (preferred) and medical device related field or business.
• Possesses knowledge and abilities to operate within an environment that requires a high degree of urgency, strong analytical and problem-solving skills, positive interpersonal skills, ability to handle multiple complex tasks simultaneously, and capable of performing as a leader.
• Strong quality assurance / control, manufacturing, laboratory, technical support, or regulatory background.

This position can be located remotely within the US, except for Colorado.

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The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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