Specialist Quality Assurance - Global Supply Quality

In this role you will be serving patients through internal collaboration with Amgens global quality teams, manufacturing sites and external engagement with suppliers of raw materials and devices. You will make key contributions to ensure high quality and right first time materials are received at the Amgen, build a resilient supply network and conclude with a positive patient experience. You will be part of Amgens Global Supply Quality team supporting oversight and maintenance of external suppliers and contract manufacturers including raw materials, packaging components, and medical devices.

• Periodic review and updates to quality agreements to ensure alignment to Amgen expectations and to address needs depending on material type.
• Documentation review and approval including: supplier records, investigation reports, Amgen quality records, and validation records.
• Evaluation and documentation of raw materials and devices for changes to incoming inspection profiles
• Oversight and completion of supplier assessments and documentation to support product complaints.
• Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships.
• Review and approval of change control records for supplier changes.
• Management of supplier audit records, ensuring on time completion and CAPA closeout activities are documented with appropriate closeout evidence.
• Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Take part in operational and quality improvement initiatives, programs, and projects.
• Develop solutions that are thorough, practical, and consistent with functional objectives

• Doctorate degree OR
• Masters degree with 4 to 6 years of experience in quality management systems or a related field OR
• Bachelors degree with 6 to 8 years of experience in quality management systems or a related field OR
• Diploma with 8+ years of experience in quality management systems or a related field.

• Minimum of 2 years working in a cGMP manufacturing environment with a demonstrable understanding of regulatory requirements and expectations.

• Experience in investigations, project management and trending and analysis
• Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing.
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).
• Desire to partner with internal and external collaborators across teams
• Understanding of industry requirements/expectations of a robust Quality Management System and documentation.

• Excellent analytical and troubleshooting skills.
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation.
• Ability to manage multiple priorities successfully.
• Team-oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills