Quality Compliance External Affairs, Senior Specialist Quality

Amgen • Thousand Oaks, CA

2d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Quality Compliance External Affairs, Senior Specialist Quality What you will do Let’s do this. Let’s change the world. Pharmacopeial Program Management Lead project management of major global pharmacopoeias (USP, Ph. Eur., JP, ChP), ensuring structured review and implementation of periodic updates. Coordinate cross-functional teams and site points of contact at global manufacturing sites to execute required changes in alignment with compliance timelines. Ensure all pharmacopeial changes are appropriately assessed, documented, tracked, and maintained in a current state within Amgen systems. Author compendial assessments within Amgen’s documentation management systems for audit readiness purposes. Regulatory Intelligence & Industry Engagement Proactively monitor early signals, emerging trends, and evolving regulatory issues impacting global operations as it relates to pharmacopoeia matters. Represent Amgen’s approved positions in external organizations and trade associations as assigned, to influence and shape pharmacopeial public standards. Liaise with regulators through industry associations, supporting advocacy and alignment efforts. Cross-Functional Collaboration Partner with internal SMEs to ensure scientific alignment on pharmacopeial developments and regulatory changes. Support knowledge-sharing across functions to enhance understanding of external landscape developments. Provide back-up support within External Affairs as needed to ensure business continuity. Networking across various Amgen functions including Quality Control, Quality Assurance, Process Development/Attribute Sciences, Material Quality, Engineering, Product Quality, Microbiology, Toxicology, GRAAS-CMC and R&D Policy. Liaise with Governmental Affairs, Supply Chain, manufacturing / development sites, External Quality (CMO) and affiliates/IDQ, as appropriate Networking with peers from other companies (e.g., at conferences or while representing Amgen’s interests in industry associations) and regulators as appropriate. Continuous Improvement & Operational Excellence Lead and contribute to continuous improvement initiatives to enhance efficiency and effectiveness of the pharmacopeial program. Collaborate with SMEs and system owners to optimize databases, tracking tools, and internal processes. Support additional projects aligned with departmental priorities and professional development opportunities. Travel Travel domestically and internationally as required (approximately up to 10%). What we expect of you We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a leader with these qualifications.

Requirements

• Doctorate degree and 2 years of quality compliance experience OR Master’s degree and 4 years of quality compliance experience OR Bachelor’s degree and 6 years of quality compliance experience OR Associate’s degree and 10 years of quality compliance experience OR High school diploma / GED and 12 years of quality compliance experience

Nice To Haves

• Background in Quality, QC, QA, Engineering desirable.
• Understand quality documentation and laboratory practices including general methodologies, specifications and product quality standards.
• Excellent communication skills for both internal conversations and when representing Amgen at external forums
• Conflict resolution
• Teamwork and Networking
• Good organization, planning and prioritization capability
• Time management
• Attention to details

Responsibilities

• Pharmacopeial Program Management Lead project management of major global pharmacopoeias (USP, Ph. Eur., JP, ChP), ensuring structured review and implementation of periodic updates.
• Coordinate cross-functional teams and site points of contact at global manufacturing sites to execute required changes in alignment with compliance timelines.
• Ensure all pharmacopeial changes are appropriately assessed, documented, tracked, and maintained in a current state within Amgen systems.
• Author compendial assessments within Amgen’s documentation management systems for audit readiness purposes.
• Regulatory Intelligence & Industry Engagement Proactively monitor early signals, emerging trends, and evolving regulatory issues impacting global operations as it relates to pharmacopoeia matters.
• Represent Amgen’s approved positions in external organizations and trade associations as assigned, to influence and shape pharmacopeial public standards.
• Liaise with regulators through industry associations, supporting advocacy and alignment efforts.
• Cross-Functional Collaboration Partner with internal SMEs to ensure scientific alignment on pharmacopeial developments and regulatory changes.
• Support knowledge-sharing across functions to enhance understanding of external landscape developments.
• Provide back-up support within External Affairs as needed to ensure business continuity.
• Networking across various Amgen functions including Quality Control, Quality Assurance, Process Development/Attribute Sciences, Material Quality, Engineering, Product Quality, Microbiology, Toxicology, GRAAS-CMC and R&D Policy.
• Liaise with Governmental Affairs, Supply Chain, manufacturing / development sites, External Quality (CMO) and affiliates/IDQ, as appropriate
• Networking with peers from other companies (e.g., at conferences or while representing Amgen’s interests in industry associations) and regulators as appropriate.
• Continuous Improvement & Operational Excellence Lead and contribute to continuous improvement initiatives to enhance efficiency and effectiveness of the pharmacopeial program.
• Collaborate with SMEs and system owners to optimize databases, tracking tools, and internal processes.
• Support additional projects aligned with departmental priorities and professional development opportunities.
• Travel Travel domestically and internationally as required (approximately up to 10%).

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree