Career Category

Job Description

The International & Distribution Quality (IDQ) team in Australia supports product in the Australian and New Zealand markets after our manufacturing sites have produced the high-quality medicines for our patients. Reporting to the Regional Head of Quality for the JAPAC region this position leads a team of quality professionals that is commercial facing and has GMP/GDP oversight over finished drug product distribution Australia and New Zealand. This GMP/GDP oversight includes Local Service Providers (LSP’s), wholesalers, local suppliers, patient support programs and product complaints to ensure our products are safe and effective. You will be responsible for establishing and maintaining open and collaborative working relationships with local Commercial and local/global Operations stakeholders. This position reports into the Regional Head of Quality for the JAPAC region.

Key Responsibilities

• Manage a team of professionals in the daily activities to support supply of product in the market.
• Recruit, train, develop, motivate and retain staff.
• Develop and implement a Quality strategy for Amgen in ANZ and develop a strong collaborative working relationship with local affiliate management, global functions as well as LSP’s and wholesalers.
• Lead and direct all aspects of the Quality function in ANZ as required by Amgen Quality policies and local regulations.
• Provide Quality oversight of LSP’s, wholesalers and suppliers of physician/patient support packages.
• Interact with the TGA and other regulatory agencies as needed to support the Quality Organization and assess new and revised regulations, standards and guidance related to GMP/GDP.
• Identify, evaluate and lead projects that improve quality and gain efficiencies.
• Develop budgets and monitor performance against them.
• Implement, maintain and improve local GMP/GDP Quality Management Systems (QMS) in accordance with local regulations.
• Provide quality oversight over the QMS including but not limited to; lot acceptance, deviations, CAPA’s, change controls, product complaints and metrics.
• Alert senior management of significant quality, compliance, supply and safety risks.
• Review and approval local SOP’s, standards, reports and documents as needed.
• Actively engage in outside activities to enhance Amgen’s reputation in ANZ.

Qualifications, skills and experience

• Bachelor’s degree and 8 years of Quality Assurance experience
•  Minimum 5 years of direct management experience
•  English language fluency
•  Demonstrated leadership of teams and ability to work cross functionally
• Strong organizational skills and ability to manage multiple tasks at one time, including the ability to follow assignments through to completion and meet timelines (commitment to task, attention to detail)
• Strong communication skills, both written and oral
• Demonstrated ability to work as both a team player and independently
• Experience with quality systems including change control, deviation, product complaints and disposition
• Experience with product launches
• Knowledge and experience of Good Distribution Practices
• Knowledge of manufacturing processes and operations
•   Skill in project management, leading, negotiating and influencing (relationship management, team work)

Closing Date - Tuesday 28th January, 2020

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If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.