Full Job Description
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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.
This person serves as one of the senior technical representatives within the QMS department(s) in the Quality organization. He/She is responsible for results in terms of management and implementation of the Product Development Lifecycle process tool and compliance to regulations and Baxter quality policies. This role is an individual contributor, it does not manage direct reports.
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
Understands and assures conformance to regulations for Change Control Management (CCM), PDLM and TcU. Interfaces with regulators during inspections. This role is responsible for creation and maintenance of rule set for configuration management for drug and biologic products.
Serves as the data architect for implementation for PLM systems to ensure where used and Product File reporting requirements are met
May participate in or lead quality assessments of internal operations and suppliers to analyze compliance and assess risk
Interacts frequently with plants, R&D, RA, Labeling and other internal supervisors, functional peer and senior leaders
Identifies and leads continuous improvement projects with the objective of achieving quality, reliability and cost improvements
Mentors, coaches, trains & develops more junior associates in the department and other functions
Required knowledge, skills, and/or abilities
Thorough knowledge of CCM and PDLM procedures, regulations and standards
Ability to mentor and serve as the internal technical expert
Drug development and transfer knowledge
Strong analytical and problem-solving skills
Strong communication and leadership skills
Strong interpersonal/communication/influencing/negotiation skills
Strong project management skills
Education and Experience
BS in science or engineering; advanced degree helpful
7 years in Quality, Manufacturing, Engineering or related field
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.