Senior Manager, Quality ANZ
Job Summary
- Market leading developer & manufacturer of medical devices for Womens Health
- Newly created role with an innovative and growing organisation
- Hybrid Working & Certified asA 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 Womens 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 aSenior Manager Quality ANZ where you will represent a leading global brand and lead the commercial quality function acrossAustralia and New 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 Hologics global quality framework. A key priority will be supporting the transition to the organisations new globalelectronic 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 acrossANZ 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 ofpostmarket surveillance activities complaint handling and investigation and ensuring regulatory reporting requirements are met across ANZ. You will lead and supportCAPA processes management reviews and internal and external audits and act as a key point of contact for regulatory interactions including communications with theTherapeutic Goods Administration (TGA).
The role also provides local quality oversight fordistribution and warehouse activities within Australia acting as the ontheground 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 aBachelors degree in a scientific disciplineand at least8 years experience in commercial quality leadership role within the medical device industry.
You are a proactive and selfmotivated leader who thrives in a fastpaced 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 highachieving and collaborativea team driven by the impact we have on our global community. We are proud of our positive team environment where worklife 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 acrossANZ 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.
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Required Experience:
Senior Manager
About Company
Hologic is a global champion of women’s health. We integrate The Science of Sure into everything we do to help improve and save lives through early detection and proactive treatment.