Quality Compliance, Senior Manager

Amgen • Thousand Oaks, CA

10d

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 Senior Manager What you will do Let’s do this. Let’s change the world. Let’s do this. Let’s change the world. In this vital role you will be responsible for driving Global Quality Compliance Audits and assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities: Coordinates, leads, or participates in Corporate Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers, to assess compliance with all applicable regulations and to identify top compliance risks. Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies. Implements risk assessments. 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). Has documented experience and working knowledge of Amgen’s competencies including but not limited to manufacturers or intermediates, API/drug substance, drug product, combination products, medical devices, and laboratories. Provides leadership toward calling out site and multi-site compliance issues resulting from audit findings. 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. Provides technical support/compliance review of multi-site/global documents resolving compliance issues, if/when necessary. Interacts with other functional leads to ensure that Amgen Standards, strategies and direction are aligned with existing regulations and regulatory expectations. Alerts senior and/or executive management of significant quality, and compliance risks. Provides support for audit and inspection metrics as vital. Supports Continual Improvement initiatives, programs and projects.

Requirements

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

Nice To Haves

• Lead Auditor Certification
• Audit Experience in Drug Substance (DS), Drug Product (DP), Finished Drug Product (FDP), Medical Device, Combination Product, and/or Active Pharmaceutical Ingredients (API), and Small Molecule
• Strong communication skills both verbal and written
• Domestic and International travel up to 50%

Responsibilities

• Coordinates, leads, or participates in Corporate Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers, to assess compliance with all applicable regulations and to identify top compliance risks.
• Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies.
• Implements risk assessments.
• 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).
• Has documented experience and working knowledge of Amgen’s competencies including but not limited to manufacturers or intermediates, API/drug substance, drug product, combination products, medical devices, and laboratories.
• Provides leadership toward calling out site and multi-site compliance issues resulting from audit findings.
• 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.
• Provides technical support/compliance review of multi-site/global documents resolving compliance issues, if/when necessary.
• Interacts with other functional leads to ensure that Amgen Standards, strategies and direction are aligned with existing regulations and regulatory expectations.
• Alerts senior and/or executive management of significant quality, and compliance risks.
• Provides support for audit and inspection metrics as vital.
• Supports Continual Improvement initiatives, programs and projects.

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
• Number of Employees: 5,001-10,000 employees