Quality Compliance, Director

About this role

Career Category Quality Job Description 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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, DIRECTOR

What you will do Let’s do this. Let’s change the world. In this vital role you will report to the Executive Director of Regulatory Compliance and primarily provide direct support for compliance related deliverables associated to new sites or expansion of existing manufacturing sites.

• Serve as a strategic partner supporting the Quality Improvement Plans (QIP) and Operational Readiness program by providing independent compliance expertise, and objective guidance to support sustained GMP readiness and operational excellence.    • Partner closely with QA Operational Readiness Team and cross-functional leadership to evaluate remediation strategies, operational readiness initiatives, and quality system enhancements, ensuring alignment with global quality standards, regulatory expectations, and enterprise best practices.   • Participate in operational readiness reviews, and Go/No-Go decision-making processes to support objective, evidence-based assessments while promoting inspection readiness, effective risk management, and the long-term sustainability of the site's Quality Management System.    • Draft and/or review regulatory communications in the form of inspection observation responses, third party audit finding responses, responses to questions associated with regulatory filings and other information requests.  • Conduct inspection readiness exercises (strategy, preparation, pressure testing) in support of both scheduled and unscheduled regulatory inspections, in coordination with the sites and Site Inspection Lifecycle Management staff.  • Assist with generation of inspection playbooks and ensure staff are prepared to present during regulatory inspections.  • Lead virtual or on-site strategy support during regulatory inspections. May lead cross-functional regulatory response teams.  • Provide direct compliance support for deviation investigation and key inspection topics. Ensure appropriate technical content and documented rationale is available in support of investigation conclusions. Participate on Investigation Advisory Boards as Advisor, as required.  • Provide compliance advice on new technologies and proposed changes to quality processes in support of continuous improvement and the implementation of new digital strategies. 

What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.

Basic Qualifications: • Bachelor’s degree and 9 years of Quality Compliance experience OR • Master’s degree and 7 years of Quality Compliance experience OR • Doctorate degree and 4 years of Quality Compliance experience

Preferred Qualifications: • Strong background in Quality Compliance within a GMP-regulated environment. • Experience supporting drug substance and bulk manufacturing operations. • Expertise in GMP compliance, inspection readiness, and regulatory requirements. • Experience with drug product manufacturing and compliance.

What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: • 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. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsor

Similar jobs

• Director, Compliance — Figure · Remote
• Director, Compliance — Dynetherapeutics · Remote
• Director, Quality Systems & Compliance — Elevatebio · Waltham, Massachusetts, United States
• Director of Compliance — Electronx · Chicago
• Director of Compliance — Commure · Mountain View, CA
• Associate Director, Quality Assurance Compliance — Gilead Sciences · Foster City, California, United States | United States – Remote
• Director, Compliance Operations — Honor · Remote
• Assurance Compliance Director — Coastal · Remote