Senior Associate, R&D Compliance

Career Category

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. 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.

Senior Associate, R&D Compliance

What you will do

Let’s do this! Let’s change the world! In this vital role you will Strengthen and advance Amgen’s R&D QMS. Provide quality support for Amgen programs for all stages of products in clinical development.

• Supports Research and Development Quality Manager (RDQ)

• GCP Resource - Provide independent and objective quality advice in support of clinical trial activities and in line with current standard methodology and lessons learned

• Participate as a member of the Clinical Study Team (CST) and attend relevant CST meetings

• Support review and provide quality input to other key study documents as needed, including, but not limited to, ICF, vendor manuals, site monitoring plan

• Provide quality oversight of key risk-based quality deliverables, including CT-RACT, Quality Oversight Plans, and other plans that involve rating of risk, monitoring risks for action, and root cause analysis to ensure that actions are commensurate with risks to patient safety, rights, welfare and trial integrity

• Support preparation, analyze and identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions and communicate quality metrics and other significant quality information on periodic basis to key collaborators

• Support Clinical Trial Teams for quality management activities, including Deviations/CAPAs, and Serious Breaches/Privacy Issues

• Support GxP training function with R&D assessments and assignments

• Collaborate with other Amgen R&D Quality functions

Quality Assurance including Audits

• Support RDQ Managers with risk-based GCP audits (investigator site audits, directed audits, affiliate audits, service provider audits and study level audits, and institutional level audits).

• Support the development of TA-specific Quality Assurance plans and site audit selection that are risk based and efficient.

• Provide support for vendor assessments/evaluations

• Support response generation for audit findings and self reported deviations

Inspection Readiness activities, and Inspection Management

• Support Clinical Study Team on review of Inspection readiness plans

• Support inspection management lead on pre-inspection activities for programs

• Support regulatory inspections of Amgen studies at investigator sites and Amgen Facilities

• Support Pre-Inspection site visits

• Support the review responses to regulatory authority inspections reports before their submission to authorities and ensure that CAPA plans are executed as required per Amgen procedures and regulatory authority commitments

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• High school/GED + 4 years quality compliance work experience OR Associate’s + 2 years quality compliance work experience OR Bachelor’s + 6 months quality compliance work experience OR Master's

Preferred Qualifications:

• Minimum of 3 years in biopharmaceutical industry experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.

• Experience supporting regulatory authority inspections of clinical research, and/or pharmacovigilance activities

• Oversight and application of Quality Management Systems and experience managing qualit