Quality Oversight Specialist
2 weeks ago
We are seeking a highly skilled Quality Oversight Specialist - Biotech Industry to join our team at Amgen, Inc. This role will provide quality support for the development and implementation of a risk-based quality assurance strategy for all stages of products in non-clinical development.
About the Job
As a Quality Oversight Specialist - Biotech Industry, you will be responsible for supporting GLP compliance oversight through cross-functional collaboration with functional areas and stakeholder groups within Research in alignment with standard practices. You will also plan, conduct and report out on risk-based R&D audits, review, negotiate and approve responses to R&D audit findings, and provide oversight for compliance activities through to finding closure.
Your Key Responsibilities
- Manage deliverables and provide data and recommendations regarding the state of quality for processes, technology, laboratory and external vendor performance.
- Support the establishment of regional expertise to ensure quality and compliance to local regulations as well as support research-specific data integrity, including technologies for data collection and measurement.
- Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods).
The Ideal Candidate
To succeed in this role, you will need experience in Quality Management, Quality Assurance or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility. You will also need experience with Quality Oversight of Nonclinical Trials, including auditing GLP phases, data and final reports, as well as partnership with third-party vendors, suppliers and partners. Additionally, you should have knowledge of the Regulatory Submission and Inspection Management procedures, excellent verbal and written communication skills, and the ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format.
We Offer
In return for your skills and experience, we offer a competitive salary of $130,000 per year, plus a range of benefits including a generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits. You will also have the opportunity to work in a diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
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