Job Description
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.
Thermo Fisher Scientific in New Zealand
Over 350 NZ employees bring a variety of skills and expertise to deliver world-class science products and solutions. Our manufacturing and distribution sites in Auckland and Christchurch (and satellite sites scattered across the country) cover a vast product portfolio, including lab equipment and chemicals, life sciences, diagnostics, microbiology and analytical instruments. We deliver science solutions to a wide range of key markets such as academia and research; diagnostics and healthcare; environmental; food, dairy and beverage; industrial process; life sciences; pharmaceutical and biopharmaceutical.
Job Title:Head of Quality, ANZ BioProduction Operations
Reports to: Sr Director, Quality
Position Location: Auckland (Penrose)
Number of Direct Reports: 8
How you'll make an impact:
You will be responsible for leading Quality teams in product testing and release processes, maintenance and development and continuous improvement of quality systems and compliance consistent with the principles of ISO and current Good Manufacturing Practices. You will contribute to development and maintenance of customer relationships including hosting technical visits and quality audits. You will monitor and measure the performance of the manufacture of products and delivery services intended to meet all pre-determined quality attributes and customer expectations. And you will develop a high performing team by motivating, challenging and coaching team members, ensuring they take accountability and facilitate on-going personal development.
What will you do?
Ensure that processes needed for the quality management system are established, implemented and maintained for LSG ANZ BPD operations in conformance with ISO9001:2015 and other quality and regulatory requirements as applicable.
Report to management on the performance of the quality management system and any need for improvement for LSG ANZ BPD operations.
Lead customer or regulatory quality audits and coordinate response and actions as needed.
Provide strategic and functional leadership and direction for the Quality teams for LSG ANZ BPD operations and liaise with global LSG BPD Quality network.
Cost effectively direct and oversee the development, planning, implementation, maintenance and measurement of quality systems methods, processes, and procedures for new and existing products and services.
Oversee the development, generation, review and approval of methods, procedures and documentation related to compliance to current Good Manufacturing Practices and / or other related compliance standards (e.g. ISO, specific customer requirements, global LSG requirements, USDA, etc.) as required and maintain knowledge of industry developments (particularly in relation to QC) that may impact on operations or customers.
Support and/or lead productivity and customer related initiatives and projects.
How will you get here?
Education:
Tertiary Science qualification
Experience
Proven team leadership
Experience working in a cGMP/ISO9001 environment in a QA role
Experience with and high level of understanding of cGMP and ISO9001/key elements of quality system
Computer literate in word processing, spreadsheets, quality and inventory systems
Experience leading external audits
Experience with regulatory affairs e.g. MPI preferable
Ability to manage complex challenges in matrix environment
Forward thinking with a delivery focus
Leadership and people coaching & development
Excellent communication skills
Computer literate in word processing, spreadsheets
Adaptable and flexible to changing customer demands and requirements
Other Job Requirements:
Travel: 25%
What’s in it for you?
A competitive salary and performance related bonus structure
Access to Thermo Fisher’s global University
Exposure to market leading cutting edge technologies.
Development opportunities as part of a rapidly growing global organisation
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
