Director, Quality Assurance APAC
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Job Summary
Are you passionate about elevating quality standards and making a real impact in healthcare Do you thrive on leading diverse teams and driving strategic initiatives across international markets
Based in Dubai or Singapore the Director Quality Assurance APAC will be responsible for managing the APAC quality organization. You will ensure high quality standards and compliance with regulatory requirements and internal policies. You will be responsible for assessing current systems and practices identifying gaps and developing comprehensive solutions to harmonize and optimize quality processes across the APAC region.
What to expect:
- Lead & Inspire: Coach develop and mentor our talented Quality team fostering growth high performance and cross-border collaboration.
- Quality Champion:Advance knowledge of QSRs ISO 13485 ISO 14971 MDSAP and IVDR and all relevant regulationsmaking compliance second nature.
- Strategic Partner: Collaborate with Regulatory Operations R&D Supply Chain Legal and Commercial teams to drive quality objectives and harmonize processes.
- Continuous Improvement:Lead Lean Six Sigma and data-driven initiatives to manage non-conformances CAPAs complaints and post-market surveillance.
- Voice of the Customer:Embed a customer-centric mindset across the organization ensuring customer needs are the foundation of every quality activity.
- Regulatory Interface: Act as primary contact for regulatory authorities notified bodies and auditors throughout APAC.
- Talent Developer:Assess organizational structure address skill gaps and coach team members to build a world-class quality function.
- Risk Manager: Proactively identify and mitigate quality risks staying ahead of regulatory changes and industry best practices.
- Training & Development: Provide annual training on audit readiness
What we expect:
- Experience: A proven track record of building new Quality functions in multiple countries/regions in APAC. Experience working within large complex organizations. Proven experience working with both IVD and medical devices and experience in bringing new products to market.
- Quality Management Systems: Expertise completing large and small scale harmonization projects.
- Post Market Surveillance:Experience creating robust PMS systems.
- Education: Bachelors degree in engineering or a related field required; Masters (MBA Quality Management Engineering) highly preferred.
- Leadership: Demonstrated success managing large diverse teams across multiple countries and cultures Strong and driven leadership skills including leading other people leaders.
- Skills: Analytical and strategic thinker. Strong problem-solving and decision-making abilities. Excellent communicator and influencer at all levels. Ability to drive accountability and empower others.
- Behaviours: Desire and capability to work cross-functionally with sales service and marketing teams including direct interaction with customers as the face of Quality
- Partnership: Maintain a working knowledge of Hologics products and other responsibilities as assigned.
- Languages: Fluency in English required; additional languages a plus.
- Travel: Willingness to travel across the APAC region as needed 15-20%.
Why Join Hologic
- Make a Difference: Impact millions of lives by ensuring the highest standards in womens health and diagnostics.
- Grow Your Career: Thrive in a global innovative and supportive environment.
- Drive Change: Be part of a company that values your ideas expertise and leadership.
Ready to make your mark Apply now to lead quality excellence at Hologic!
#LI-RH1
Required Experience:
Director
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
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.
