Quality Manager, Commercial

1 month ago

Old Toongabbie, Australia Baxter Full time

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 Role

We 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 maintained

Delegate authority to personnel responsible for various aspects of the QMS

Report on the performance of the QMS and any need for improvement to the highest level

Ensure field surveillance activities are executed

Ensure product safety risks are effectively evaluated, managed, communicated, and documented

Maintain the integrity of the QMS when changes to the QMS are planned and implemented

Promote the awareness of regulatory and customer requirements throughout the organization

Approve or reject components, containers, closures, in-process materials, packaging material, labeling, and final products

Ensure and maintain the GMP compliance for Pharma

Review production/quality records to ensure that exceptions have been appropriately addressed

Perform and Lead Internal Auditing

Prepare and lead management review meetings

Lead and coordinate Supplier Quality activities

Manage and lead nonconformance and CAPA.

Key Requirements of the role include:

Tertiary degree in Science or related fields

Minimum of 10 years’ experience in Quality, Manufacturing or related fields in the medical products industry

7 or more years management experience, preferably in a global organization

Strong understanding and working knowledge of FDA, TGA (PIC/S) and Medical Device Regulations, Application of Good Manufacturing Practices

Comprehension 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 regarded

Highly developed interpersonal effectiveness and relationship-building abilities

Collaborative 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.

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.

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