Quality Systems and Compliance Manager

About Toll Group

At Toll, we do more than just logistics - we move the businesses that move the world. Our 16,000 team members can help solve any logistics, transport, or supply chain challenge - big or small. We have been supporting our customers for more than 130 years. Today, we support more than 20,000 customers worldwide with 500 sites in 27 markets, and a forwarding network spanning 150 countries. We are proudly part of Japan Post —

At Toll Healthcare, we are committed to investing in our people's professional development. Enjoy the benefits of a hybrid working model while contributing to our mission of delivering excellence in healthcare logistics.

Are you ready to elevate your career with Toll Healthcare? Join our dynamic and supportive team as the Manager, Quality Systems and Compliance, reporting directly to the Senior Manager - National Quality Assurance, Healthcare. With six healthcare facilities nationwide and a new build underway, this role offers a fantastic opportunity to leverage your in-depth knowledge of TGA regulations, GMP, and relevant ISO standards to support our national operations.

As a highly experienced quality systems and compliance expert, you will ensure adherence across sourcing, warehousing, and distribution, while promoting continuous improvement. You will manage the site validation program to ensure the timely completion of all validation activities and develop and deliver training programs to enhance Quality standards and culture. Your expertise in quality systems, compliance coupled with a customer-centric attitude will be crucial for your success. A basic understanding of supply chain management and integrated logistics, including experience in validation processes such as transport, packaging, and temperature mapping would also be highly beneficial.

Key Responsibilities:
- Vendor Assurance Program: Manage supplier qualification, vendor audits, and draft Quality Agreements.- Audit Programs: Oversee internal and external audits, conduct internal audits, and lead preparatory activities for regulatory inspections.-
- Quality KPIs: Develop, monitor, and trend Quality KPIs and objectives.- Quality Systems Improvement: Identify and implement improvements to Quality systems.- Management Review Reports: Prepare periodic management review reports.- Compliance Management: Oversee change control, customer complaints, CAPA, and non-conformance management systems.- Quality Training Program: Manage the quality training program to ensure compliance.- Site Validation Program: Ensure timely completion of all validation activities.- Tender Responses: Assist with the preparation of tender responses.- Quality System Procedures: Develop and implement Quality System procedures.- QA Reviews: Conduct QA reviews and approvals of Quality System documentation.- Training Programs: Develop and deliver training programs to enhance Quality standards and culture.- Customer Review Meetings: Participate in customer review meetings.

Essential Technical and Skill Requirements:
- Excellent knowledge of TGA regulations, GMP, GWP, state poisons licence requirements, and relevant ISO standards (ISO 9001, ISO 13485).- Prior experience in logistics sites.- In-depth understanding of Quality Management Systems (QMS) principles and software.- Experience with internal and external audits.- Familiarity with risk management and mitigation strategies.- Knowledge of root cause analysis and corrective action implementation.- Proficiency in regulatory compliance and industry-specific standards.- Experience with documentation and record-keeping for compliance activities.- Experience with training and educating staff on quality standards and procedures.

Qualifications:
- Science degree or equivalent.- Minimum of 12 years of relevant Quality experience in consumer health/pharmaceutical/medical devices or diagnostics.- Driver’s Licence (car).

What moves you?

At Toll, you can help play a vital role in delivering what matters. From food, fuel, medicine and rescue services, we keep businesses and communities thriving. Every day brings change. We see that as an opportunity. To be curious. To ask the right questions. And build meaningful connections. Because finding new ways to solve problems is what we do. With a bold vision to expand our global reach, our 16,000+ people bring a passion for progress. We collaborate in friendly, caring teams, supported by approachable leaders who give us the autonomy to quickly make decisions with impact. Learn and grow with industry-leading training, alongside talented experts. Feel empowered to take on diverse challenges and new responsibilities to move you, our customers, and our world further.

At Toll everyone is welcome including those of all ages, ethnicities, genders and abilities.

You must be entitled to work in Australia and be prepared to undertake pre-employment checks including a criminal history check and medical.