The Quality Assurance Manager oversees QA functions in the diagnostics division, ensures compliance with regulations, and leads quality improvements across affiliates.
JOB DESCRIPTION:
AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:• Career development with an international company where you can grow the career you dream of .• Amazing health and wellness benefits and perks.• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
This position works for Corelab. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
Main purpose of the role
Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:• Career development with an international company where you can grow the career you dream of .• Amazing health and wellness benefits and perks.• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
This position works for Corelab. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
Main purpose of the role
- This position leads the QA function in Abbott ANZ Core Diagnostics division, Molecular Diagnostics and Point of Care (as part of shared services.)
- Ensuring Commercial Affiliate / Regional quality system meets the requirements of applicable external standards and regulations.
- Responsible for ANZ Core Dx Commercial Affiliates in all GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) Quality activities.
- Primary point of contact for all QA matters related to ANZ Core Dx Representative Office.
- Provide expertise to the ANZ Commercial Affiliates to Improve and maintain the quality system.
- Accountable for Post Market activities in ANZ including complaint related tasks Recalls, Field Action communication and activities including Recalls, Advisory Notices etc and participate in the execution
Responsibilities:
- Develop and implement overall quality strategy for Aust. & NZ to ensure compliance to regulatory requirements, company policy and ISO9001 requirements.
- Manage the risk to business operations by ensuring appropriate actions are taken to address all non-compliance issues and continuous improvement opportunities
- Build and maintain strategic relationships with Global and Regional personnel to maximise data and information exchange for business planning.
- Report the performance of the Management System to the local executive Management.
- Provide advice on quality related matters for regulatory, marketing, logistics and other corporate functions as required.
- Ensure awareness of regulatory and Quality requirements throughout the Commercial Affiliate;
- Ensure liaison with external parties on matters relating to the Management System.
- Assist in training staff on Quality systems
- On a timely basis, prepare or arrange for preparation of Quality budgets, reports and forecasts.
- Facilitates audits and regulatory inspections.
- Liaises with external vendors, contractors or suppliers to ensure that their products or services meet the organisation's quality standards.
Minimum Education
- Degree graduate in Chemistry, Microbiology, Pharmacy, Engineering or Science related discipline.
- Detailed knowledge of how regulatory bodies in Australia and associated countries operate.
Minimum Experience/Training Required
- Minimum 7 years regulatory experience within the diagnostics industry in a Quality, Regulatory or R&D function.
- ISO 13485, GMP and GDP knowledge
- Good communication and negotiation skill to facilitate implementation of complex technical solutions and must possess independent decision making skills.
- Quality Auditor Certification ( Preferable)
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:CRLB Core Lab
LOCATION:Australia > Macquarie Park : 299 Lane Cove Road
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Top Skills
Gdp
Gmp
Iso13485
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