Senior Manager Corporate Quality Compliance

Amgen • Thousand Oaks, CA

3d • Hybrid

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is a biotechnology company focused on pioneering the world of biotech in its fight against the world’s toughest diseases. With a focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – Amgen reaches millions of patients each year. The Global Quality Compliance department is seeking a Senior Manager to help make a lasting impact on patients' lives by researching, manufacturing, and delivering innovative medicines. The award-winning culture at Amgen is collaborative, innovative, and science-based, offering opportunities for those with a passion for challenges.

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
• A minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• Experience with Aseptic Processing, Drug Product, Drug Substance, Combination Products, Data Integrity

Nice To Haves

• Certified Quality Auditor (CQA) or equivalent
• Auditing experience in internal audit, affiliate, CMO, Contract laboratory, Transportation/Logistic/Distribution/ warehouse services
• Knowledge of international regulations and standards
• Auditing certification preferred
• Detail oriented
• Organizational and multi task skills

Responsibilities

• Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals.
• 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 expectations.
• 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: Senior
• Education Level: No Education Listed