Quality Manager, Commercial

This is where you save and sustain livesAt 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 RoleWe have an exciting opportunity for a Quality Manager to join our RAQA team at Baxter. Reporting to the Head of QARA ANZ you will work to understand, implement, maintain, and continually improve the efficiency of the Baxter Quality Management System.With a key focus on Quality leadership, your role will include working on setting up systems and processes ensuring regulatory compliance, as per applicable regulation and standard. As the Quality Management Representative, you will ensure that measurable quality objectives and goals are consistent with the quality policy. You will lead, manage and develop a team of RAQA Specialists, while partnering closely with key internal and external stakeholder across the Baxter organisation.If you are a passionate quality professional looking to make a significant impact on patient lives, we’d love to hear from you!This is where you can do your best work. Where your purpose accelerates our mission.Key Responsibilities:Ensure QMS requirements are effectively established and maintainedDelegate authority to personnel responsible for various aspects of the QMSReport on the performance of the QMS and any need for improvement to the highest levelEnsure field surveillance activities are executedEnsure product safety risks are effectively evaluated, managed, communicated, and documentedMaintain the integrity of the QMS when changes to the QMS are planned and implementedPromote the awareness of regulatory and customer requirements throughout the organizationApprove or reject components, containers, closures, in-process materials, packaging material, labeling, and final productsEnsure and maintain the GMP compliance for PharmaReview production/quality records to ensure that exceptions have been appropriately addressedPerform and Lead Internal AuditingPrepare and lead management review meetingsLead and coordinate Supplier Quality activitiesManage and lead nonconformance and CAPA.Key Requirements of the role include:Tertiary degree in Science or related fieldsMinimum of 10 years’ experience in Quality, Manufacturing or related fields in the medical products industry7 or more years management experience, preferably in a global organizationStrong understanding and working knowledge of FDA, TGA (PIC/S) and Medical Device Regulations, Application of Good Manufacturing PracticesComprehension of design methodology, product configuration and complex manufacturing processes.Ability to work under strict deadlines and changing priorities with minimal supervision.Project management experience is highly regardedHighly developed interpersonal effectiveness and relationship-building abilitiesCollaborative approach and ability to work well with others.Why Baxter?At Baxter ANZ, we are focused on being a Best Place to Work where our people can be their authentic self, feel valued and respected. We are committed to a culture where all employees can collaborate and work together effectively.Relationships are a key component in how we operate in Baxter and we share the common traits of being reliable, ethical, caring, having empathy, actively listening to our colleagues as well as being open minded to new ideas and perspectives. Baxter is an organisation that makes inclusion and diversity a priority and that seeks to promote and improve gender equality in the workplace.We are proud to be recognised among the top 120 companies for the seventh consecutive year as an Employer of Choice for Gender Equality for delivering support structures for working families; stronger actions to address pay inequalities; and strategic recruitment and promotion practices that help to encourage the full participation of women at work. We are also pleased to be the winner of the 2021 & 2019 Women in MedTech Champion Company Award.Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.Situated in Western Sydney, and featuring and onsite cafeteria and café, gym, we offer a dynamic and future focused work environment offering workplace flexibility, development & career growth, volunteering leave, 12 weeks parental leave, income protection insurance and a strong value driven culture focused on diversity, equality, and inclusion.Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or any other status protected by law. Baxter encourages applicants of all ages.Reasonable AccommodationsBaxter 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 here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter 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 .