Associate Director, RAQA, ANZ at Baxter International Inc.

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

08 Feb, 26

Salary

0.0

Posted On

10 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Quality Assurance, Leadership, Communication, Interpersonal Skills, Team Development, Regulatory Affairs, Analytical Skills, Negotiation, Cross-Cultural Leadership, Product Lifecycle Management, Quality Systems, Customer Communication, Technical Support, Continuous Improvement, Problem Solving

Industry

Medical Equipment Manufacturing

Description

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. The Role We are seeking an expert and skilled professional to join our team as an Associate Director, RAQA ANZ. In this leadership role you will manage and lead the day-to-day activities of the ANZ Quality and Regulatory Affairs team. Your role will be pivotal in providing guidance on regulatory compliance and quality assurance, by applying a detailed understanding of regulatory/standards requirements to one or more areas of expertise in regulations, pharmaceutical and medical device regulations for ANZ. Reporting to the Senior Director, QARA for APAC, you will provide strategic regulatory expertise to support market access of the products in ANZ, while sitting in the ANZ leadership team and APAC RAQA Leadership teams represent CQARA function. You will bring strong communication and interpersonal skills to represent Baxter and collaborate with TGA, Medsafe, MTAA, and internal teams including Commercial, Manufacturing, Medical Affairs and Pharmacovigilance (PV) teams. If you are a motivated and experienced QARA professional looking for a new challenge, we encourage you to apply! Key Responsibilities Provide leadership in planning and execution of ANZ regulatory strategies for new and existing products Coordinate and lead regulatory and certification inspections as well as all communications with regulatory and certification agencies Ensure adequate resourcing and direct activities of QA/RA professionals and delegates providing support to local business Prepare, update, and implement regulatory operational plans to deliver desired regulatory outcomes Oversee all quality related strategies, policy and process, optimization and ensure maintenance of quality system align with corporate and regulatory requirements Manage regulatory deliverables throughout the product lifecycle Lead regulatory policy shaping in partnership with Government Affairs colleagues Monitor product quality, coordinate communication, and ensure corrective actions with manufacturers Manage the ANZ Audit and CAPA systems Prepare and submit required quality documents, exercising considerable judgment Coordinate and lead regulatory inspections and communications with agencies Ensure adequate resourcing and direct activities of QA/RA professionals Establish and implement policies for effective product regulatory submission preparation and management Develop ANZ regulatory plans for new products and set standards for promotional activities Ensure good communication with customers and authorities to maintain the company's quality image Work effectively with local authorities, testing authorities, manufacturers, and suppliers to ensure product compliance Ensure robust Management Review and internal audit processes for continuous improvement Provide technical support in the investigation and handling of quality issues and customer complaints. Key Requirements Tertiary degree in Pharmacy/Science, or related fields with Postgraduate qualifications in business or related areas are advantageous Up to 15 years of experience in the pharmaceutical or medical device industry is required for this role 10 years or more of developing Quality Assurance responsibility in pharmaceuticals and/or medical devices, and 5 years in Regulatory Affairs preferably in a global company Demonstrated success in leading and developing teams Experience with drug/medical device registration and quality regulations in ANZ Attention to detail and a sound scientific knowledge base Strong communication skills with internal and external collaborators Skilled in negotiating and experience collaborating with regulatory authorities and partners Strong cross-cultural leadership and communication skills Ability to build strong collaborative relationships with external authorities Demonstrated ability to lead, mentor, and develop others Experience with TGA/MDSAP submissions and audits Strong analytical, leadership, and assessment skills Strong verbal and written communication skills Flexibility to manage multiple tasks simultaneously Dedication to meeting deadlines and tasks. 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. 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. No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.

Responsibilities

The Associate Director will manage the day-to-day activities of the ANZ Quality and Regulatory Affairs team, providing guidance on regulatory compliance and quality assurance. This role involves leading regulatory strategies, overseeing quality-related policies, and ensuring effective communication with regulatory agencies.