Head of QAra, Anz

**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.

**About Baxter**

Baxter provides a broad portfolio of essential Hospital products, sterile IV solutions; infusion systems and devices; parenteral nutrition; surgical products and pharmaceuticals; and pharmacy automation, software and compounding services.

The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Driven by our culture and our values, we lead with insights, ideas and outcomes meaningful to our business success. We are experts in our field, and we continue to learn and grow every day, striving to learn more about our customers and the world around us. Our way of working is open and collaborative with a focus on building trusted and ongoing relationships with all stakeholders.

Baxter and Hillrom are uniting to meet the challenges of a rapidly-evolving healthcare landscape. Together, we will enable care efficiencies, improve care outcomes and broaden access to care in the hospital, home and alternate care settings

**The Role**

Role responsibilities include (but not limited to):

- Provides leadership in planning and execution of ANZ Regulatory strategies for new products as well as for the maintenance of existing products
- Prepare, update, and implement regulatory operational plans to deliver regulatory outcomes of the assigned products/projects.
- Manage regulatory deliverables of the assigned products/projects throughout the product’s lifecycle.
- Lead regulatory policy shaping as required and in partnership with Government Affairs colleagues where necessary
- Monitor the quality of products imported and ensures necessary communication and corrective actions are coordinated with the manufacturers.
- Responsible for management of the ANZ Audit and CAPA systems.
- Exercising considerable judgment in determining approach, researches, prepares and submits required quality documents, to include those in response to documents issued by regulatory authorities.
- Coordinate and lead regulatory and certification inspections as well as all communications with regulatory and certification agencies. Responsibilities in this area are broad and complex with errors in judgment or failure to act having serious consequences to the business.
- Ensure adequate resourcing and direct activities of QA/RA professionals and delegates providing support to local organization. Be directly responsible for managing and leading the ANZ QARA team.
- Establish and implement policies and procedures to ensure timely and effective product regulatory submission preparation and management
- Work with Global Segment RA to develop ANZ regulatory plan for new products and in setting standards for company promotional activities.

**About You**
- Minimum 15 years pharmaceutical and /or medical device experience.
- Minimum 10 years of increasing Quality Assurance responsibility in pharmaceuticals and/or medical devices, and 5 years in Regulatory Affairs preferably in multinational company.
- Submission experience and Audit experience with TGA/Medsafe
- Minimum of 10 years’ experience directly managing teams.
- Demonstrated success in effectively leading and developing teams.
- Medical Device experience is preferred.
- Quality assurance experience is required.

**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 Choi