Quality Compliance Senior Manager

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.

Quality Compliance Senior Manager, Therapeutic Area Quality

What you will do

Let’s do this. Let’s change the world. In this vital role you will report to the Therapeutic Area Quality Lead - Clinical & Research Quality (CRQ). The Senior Manager, Clinical Quality provides proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy for the clinical development program. In addition, this role will focus on preparation and management for Regulatory Inspections.

Each Senior Manager, Quality Compliance will support end to end quality oversight within one of four Therapeutic Areas (TAs): Oncology; Rare Diseases; General Medicine; Inflammation and Biosimilars. Each Senior Manager, Quality Compliance is responsible for supporting a risk-based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals).

You will play a vital role by developing deep knowledge of the clinical trials you support and provide oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.

Responsibilities

• Manage/support regulatory inspections and provide guidance and feedback on responses to health authorities, including root cause and CAPA plans.

• Serve as a GCP Subject Matter Expert, providing independent and objective quality advice in support of clinical trial activities and in line with current best practice.

• Provide quality oversight for Amgen programs for all stages of products in clinical development.

• Plan, conduct and report out on risk-based GCP audits (investigator site audits, affiliate audits, service provider audits, and study level audits) or support outsourced audits.

• Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare, and rights.

• Support monthly meetings with clinical program level leaders to review quality and compliance related risks, including but not limited to: on-going quality issues/deviations, quality trends, program filing timelines, potential inspections, and risks related to other programs.

• Support response generation for audit findings and self-reported deviations.

• Support the establishment of regional expertise to ensure quality and compliance to local regulations.

• Conduct new vendor qualifications/evaluations in a risk-based manner.

• Prepare, 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 team members.

• Support TA-specific oversight of key technologies, including technologies for endpoint data collection and measurement (e.g., biomarker usage and imaging methods).

• Support the development of TA-specific Quality Assurance plans that are risk based and efficient. This includes protocol specific audit plans, and the execution of audits using various methods (e.g., remote, or on-site).

• Support Clinical Trial Teams for all quality management activities, including management of quality events (e.g., Deviations/CAPAs, Serious Breaches/Privacy Issues, Inspection Readiness activities, and Inspection Management).

• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-based, data analytics that may leverage AI and Natural Language Processing,