Senior Manager, Quality ANZ at Hologic, Inc.

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

11 Aug, 26

Salary

0.0

Posted On

13 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, Regulatory Compliance, Post-Market Surveillance, Complaint Handling, CAPA Processes, Internal Auditing, External Auditing, Stakeholder Management, TGA Regulations, Medical Device Quality, Commercial Quality Leadership, Cross-functional Collaboration

Industry

Medical Equipment Manufacturing

Description

* Market leading developer & manufacturer of medical devices for Women’s Health * Newly created role with an innovative and growing organisation * Hybrid Working & Certified as "A Great Place to Work®!" by Great WorkPlaces AU” Are you looking for a place where the work you do is directly connected to positively impacting lives around the world? Are you searching for an opportunity that allows you to focus on your strengths each day? Let us start a conversation. Hologic is an innovative medical technology company primarily focused on improving Women’s Health and well-being through early detection and treatment. We develop, manufacture and supply life-changing Diagnostics, GYN Surgical and Breast & Skeletal Solutions that are founded on science and driven by technology; allowing healthcare professionals to diagnose and proactively treat patients with growing certainty, precision, and greater peace of mind. Join us as a Senior Manager, Quality ANZ, where you will represent a leading global brand and lead the commercial quality function across Australia and New Zealand. In this newly created role, you will ensure high quality standards and compliance with regulatory requirements and internal policies while supporting the continued growth of the ANZ business. You will oversee the implementation and ongoing effectiveness of the ANZ Quality Management System, ensuring alignment with Hologic’s global quality framework. A key priority will be supporting the transition to the organisation’s new global electronic Quality Management System, helping implement and embed the new structure locally. Working closely with regional and global quality teams, you will help drive consistency, efficiency, and strong adoption of quality processes. This role requires collaboration with stakeholders across ANZ, APAC, EMEA and global teams, supporting quality harmonisation initiatives and ensuring local processes align with global standards. As the ANZ quality lead, you will play an important role in maintaining compliance while driving continuous improvement across commercial operations. Key responsibilities will include oversight of post‑market surveillance activities, complaint handling and investigation, and ensuring regulatory reporting requirements are met across ANZ. You will lead and support CAPA processes, management reviews, and internal and external audits, and act as a key point of contact for regulatory interactions, including communications with the Therapeutic Goods Administration (TGA). The role also provides local quality oversight for distribution and warehouse activities within Australia, acting as the on‑the‑ground quality partner should issues arise and collaborating with global operations teams to investigate and resolve concerns. To be successful in this role, you will bring a Bachelor’s degree in a scientific discipline and at least 8 years’ experience in commercial quality leadership role within the medical device industry. You are a proactive and self‑motivated leader who thrives in a fast‑paced environment. With strong communication and stakeholder management skills, you are comfortable influencing across functions and working closely with multiple stakeholders to deliver outcomes. To be the best, we want the best. In return, you will be joining a team that is talented, high‑achieving, and collaborative—a team driven by the impact we have on our global community. We are proud of our positive team environment where work‑life balance, engagement, and employee wellbeing are priorities. We offer a competitive salary based on experience, participation in an annual bonus structure, and a flexible working environment where many of our employees work hybrid between home and the office. This role will require occasional travel across ANZ and the broader APAC region. We make hiring decisions based on your experience, skills, and passion. Please note that interviews may be conducted virtually. When you apply, please tell us the pronouns you use and any reasonable adjustments you may need during the interview process If you are driven by the pursuit of a healthier & more enriched life for yourself, family & those around you, please apply. #LI-TL1

Responsibilities

Lead the commercial quality function across Australia and New Zealand, ensuring compliance with regulatory requirements and internal policies. Oversee the implementation of the global electronic Quality Management System and manage post-market surveillance and TGA interactions.