Senior Manager Corporate Quality Compliance

Amgen • Thousand Oaks, CA

15h

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. Global Quality Compliance, Senior Manager What you will do Let’s do this. Let’s change the world. Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities:

Requirements

• Doctorate degree and 2 years of auditor experience OR Master’s degree and 6 years of auditor experience OR Bachelor’s degree and 8 years of auditor experience OR Associate’s degree and 10 years of auditor experience OR High school diploma / GED and 12 years of auditor experience
• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• Your managerial experience may run concurrently with the required technical experience referenced above
• Experience with Aseptic Processing, Drug Product, Drug Substance, Combination Products, Data Integrity
• Certified Quality Auditor (CQA) or equivalent
• Travel: Domestic and International Approximately 50%

Nice To Haves

• Auditing experience in internal audit, affiliate, CMO, Contract laboratory, Transportation/Logistic/Distribution/ warehouse services, 50 % international travel requirement
• Knowledge of international regulations and standards
• Auditing certification preferred
• Detail oriented
• Organizational and multi task skills

Responsibilities

• Coordinates and leads or participates in Global Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, Critical Service Providers, Suppliers, Partners, and Wholesalers to assess compliance with all applicable regulations and to identify top compliance risks.
• Ensure completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to regulations, guidelines and standards, trends and expectations, as applicable).
• Supports preparation of the annual audit plans, as assigned
• Assesses state of compliance with appropriate regulations and participation in the assessment of action plans to correct deficiencies.
• Provides technical and organizational leadership toward resolving site and multi-site compliance issues.
• Alerts executive management of significant quality, and compliance risks.
• Serves as subject matter expert on global regulated requirements and inspectional commitments, as applicable
• Provides support for domestic and international Regulatory Authority Inspections when necessary.
• Serves as senior Global Quality Compliance representative on cross-functional teams (e.g., QMS, GPO, ALF, and special task forces) and interacts with other departments in order to achieve goals.
• Interacts with other functional area leads to ensure that Amgen Standards , strategies, and direction are aligned with existing regulations and regulatory expectation s .
• Provides support for audit and inspection metrics, as necessary .
• Supports Continual Improvement initiatives, programs, and projects.
• Owns or performs QA approval for DQMS Quality Event records (Quality Incident, Deviation, CAPA, Change Control, EV for GQC and Audits & Inspections network as required).

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, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees