Senior Manager, Corporate Quality Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and participate in Global Quality Compliance audits of corporate quality management systems, Amgen locations, contract facilities, affiliates, critical service providers, suppliers, partners, and wholesalers.

• Ensure the completion, maintenance, and sustainability of audit training specific to roles.

• Assist in the preparation of annual audit plans.

• Evaluate compliance with relevant regulations and engage in action-plan assessments to address deficiencies.

• Provide technical and organizational leadership to resolve compliance issues across sites and multiple sites.

• Notify executive management of significant quality and compliance risks.

• Act as a subject matter expert on global regulatory requirements and inspection commitments.

• Assist with both domestic and international Regulatory Authority inspections.

• Represent Global Quality Compliance on cross-functional teams and collaborate with various departments.

• Ensure that Amgen standards, strategies, and directions are aligned with regulations and expectations from regulatory bodies.

• Support metrics related to audits and inspections.

• Contribute to continuous improvement initiatives, programs, and projects.

• Own or perform QA approval for DQMS Quality Event records within the GQC and Audits & Inspections network.

⛳️ Requirements

• Proficiency in Aseptic Processing, Drug Product, Drug Substance, Combination Products, and Data Integrity.

• Certified Quality Auditor (CQA) or equivalent certification.

• Willingness to travel approximately 50% domestically and internationally.

• Doctorate degree with 2 years of auditing experience OR Master’s degree with 6 years of auditing experience OR Bachelor’s degree with 8 years of auditing experience OR Associate’s degree with 10 years of auditing experience OR high school diploma/GED with 12 years of auditing experience.

• At least 2 years of experience in people management and/or leadership experience in directing teams, projects, programs, or resource allocation.

• Experience in auditing within internal audit, affiliate, CMO, contract laboratory, transportation/logistics/distribution/warehouse services.

• Understanding of international regulations and standards.

• Strong attention to detail.

• Excellent organizational and multitasking abilities.

🏝️ Benefits

• Retirement and Savings Plan featuring generous company contributions.

• Comprehensive group medical, dental, and vision coverage.

• Life and disability insurance coverage.

• Flexible spending accounts available.

• Discretionary annual bonus program.

• Stock-based long-term incentives offered.

• Award-winning time-off plans.

• Flexible work models, including remote and hybrid work arrangements where feasible.

• Opportunities for career development.

• Support for work/life balance.