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.
Responsibility:
Be accountable for Drug MAH Quality system to oversight the contact manufacturing facilities, evaluate any quality related risk, perform product market release and drive the QMS continuous improvement.Be the quality head and build up and maintain drug MAH quality system quality, ensure compliance with regulation expectation and standardBe accountable for manufacturing license (category B) related application, certification and renewal.Lead relevant functions to conduct the quality assessment & audit to CMO, and discuss & align quality agreement with CMO, ensure CMO’s capability can meet related regulation Standard and Baxter requirement. Ensure the suppliers are qualified and approved following Baxter global QMS requirements.Be accountable for product market release, delegate qualified person for product release if applicableResponse for tracking quality related regulation changes, lead different SMEs to conduct GAP analysis, report and align action plans with management team, make sure regulation compliance within drug MAH organization.Organize and implement periodic on-site audits in CMO facilities.Ensure the oversight and communication mechanism is been setup and implemented effectively between MAH and CMO.Response for Baxter GQP compliance when applicableActively engage with local authority and testing center, communicate and report in time when necessaryLead complaint handling, push and review CMO or other functions investigationCommunicate with the management team about significant quality risk during quality activities and provides recommended process improvement to management team, reduce the quality risk by conducting mitigation actionsResponsible for coordinating the recall management of MAH organizationWhat We OfferAt Baxter Healthcare Corporation, we believe in fostering a positive and supportive work environment. We offer:
Competitive salary and benefits package.Opportunities for professional growth and development.A collaborative and inclusive culture that values diversity.The chance to work on impactful projects that make a real difference.Join us and be a part of a team that is dedicated to delivering world-class healthcare solutions. We look forward to welcoming you to Baxter Healthcare Corporation.
Why Join UsAt Baxter Healthcare Corporation, we believe in fostering a collaborative and inclusive work environment where every individual's contributions are valued, and they are empowered to succeed. As a Senior Product Manager, you will have the opportunity to work with a team of professionals who demonstrate a strong commitment to making a difference in patients' lives. We offer a competitive compensation package and provide ample opportunities for professional growth and development.
Equal Opportunity EmployerBaxter is an equal opportunity employer and is committed to providing employment opportunities to all qualified individuals, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.