Quality Compliance External Affairs, Senior Specialist Quality

📋 Description

• • Amgen is seeking a highly motivated and experienced Quality Compliance External Affairs, Senior Specialist Quality to join our mission of serving patients living with serious illnesses. This role is pivotal in ensuring Amgen's adherence to global pharmacopeial standards and actively shaping the external regulatory landscape.
• • As a Senior Specialist, you will take the lead in managing major global pharmacopoeias, including USP, Ph. Eur., JP, and ChP. This involves overseeing the structured review and implementation of periodic updates, ensuring Amgen remains compliant with evolving standards.
• • You will be responsible for coordinating cross-functional teams and site points of contact across Amgen's global manufacturing sites. Your leadership will ensure that all required changes are executed efficiently and in alignment with critical compliance timelines, minimizing any potential disruption to operations.
• • A key aspect of this role is ensuring that all pharmacopeial changes are meticulously assessed, thoroughly documented, and consistently tracked within Amgen's robust documentation management systems. This proactive approach is crucial for maintaining audit readiness and demonstrating compliance to regulatory bodies.
• • You will author detailed compendial assessments, providing clear and concise documentation that supports internal audits and regulatory inspections, thereby reinforcing Amgen's commitment to quality and compliance.
• • In the realm of Regulatory Intelligence and Industry Engagement, you will proactively monitor early signals, emerging trends, and evolving regulatory issues that have a significant impact on global operations, particularly concerning pharmacopoeia matters. This foresight allows Amgen to anticipate and adapt to changes effectively.
• • You will have the opportunity to represent Amgen's approved positions in external organizations and influential trade associations. This engagement is vital for influencing and shaping public pharmacopeial standards, ensuring they are practical and scientifically sound for the industry.
• • A significant part of your role will involve liaising with regulators through industry associations, actively supporting advocacy efforts and promoting alignment between Amgen's practices and regulatory expectations.
• • Collaboration is at the heart of this position. You will partner closely with internal Subject Matter Experts (SMEs) to ensure scientific alignment on pharmacopeial developments and regulatory changes, fostering a unified approach to compliance.
• • You will actively support knowledge-sharing initiatives across various functions, enhancing the collective understanding of external landscape developments and their implications for Amgen's operations.
• • To ensure business continuity, you will provide essential back-up support within the External Affairs team, demonstrating flexibility and a commitment to team success.
• • This role requires extensive networking across diverse Amgen functions, including Quality Control, Quality Assurance, Process Development/Attribute Sciences, Material Quality, Engineering, Product Quality, Microbiology, Toxicology, GRAAS-CMC, and R&D Policy. You will also liaise with Governmental Affairs, Supply Chain, manufacturing/development sites, External Quality (CMO), and affiliates/IDQ as appropriate, building strong internal relationships.
• • Furthermore, you will network with peers from other pharmaceutical companies, both at conferences and while representing Amgen's interests in industry associations, as well as with regulators when appropriate, expanding Amgen's external influence and knowledge base.
• • In terms of Continuous Improvement and Operational Excellence, you will lead and contribute to initiatives aimed at enhancing the efficiency and effectiveness of the pharmacopeial program. This includes optimizing processes and workflows to ensure maximum impact and resource utilization.
• • You will collaborate with SMEs and system owners to refine and optimize databases, tracking tools, and internal processes, driving operational excellence and ensuring the smooth functioning of the pharmacopeial program.
• • This role also offers opportunities to support additional projects aligned with departmental priorities and your professional development, fostering continuous learning and growth.
• • The position requires domestic and international travel as needed, estimated at approximately up to 10%, to engage with global sites, attend conferences, and participate in external meetings.
• • By joining Amgen, you will contribute to a collaborative, innovative, and science-based culture, helping to pioneer the future of biotechnology and make a lasting impact on patient lives.