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.

Senior Manager, Quality & Compliance

LIVE

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 Quality, Clinical & Research Quality (CRQ). As the Senior Manager, Quality & Compliance, you will play a crucial part in our mission, providing proactive end-to-end quality support for developing and implementing a risk-based quality assurance strategy for the clinical development program.

The R&D Process Quality team supports the Quality Management System (QMS) across all Amgen research areas, including discovery through the clinical development lifecycle. This team ensures that all Amgen’s business procedures meet internal and external quality standards and are managed for optimum efficiency and effectiveness. The Process Quality team also ensures that Amgen’s R&D Business Process Network develops and manages fit-for-purpose standards (SOPs) that are continuously improved upon using quality by design (QbD) and risk management methods, including QMS analytics showing quality signals and trends.

Responsibilities

• Create and maintain data tools to enable stakeholders to ensure quality in the R&D space

• Maintain Quality oversight related to continuous improvements (CI) associated with our QMS through metrics and key performance indicators (KPIs)

• Supports the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network to enable Management Reviews (periodic review by management to ensure QMS health is maintained).

• Ensures our CI efforts maintain a quality culture throughout the R & D and GDO organizations.

• Ensures that all procedures are written clearly for driving Amgen’s research tasks within a diverse, complex, cross-functional team of researchers and a rapidly evolving worldwide regulatory framework.

• Partner with the Business Process Owner network by ensuring risk-based improvements to procedures to ensure that they are simple, efficient, and fit for purpose while maintaining regulatory compliance.

• Applies risk methodologies to support audits across the R&D network that will ensure improvements to procedures through robust root cause analysis and CAPA aimed at improving procedures.

• Applies industry standard methodologies for optimal (standardized and lean) procedural documentation and the use of technology to drive an efficient and effective knowledge management system.

• Serve as a GCP Subject Matter Expert, providing independent and objective quality advice supporting business procedures managed by Business Process Owners (BPOs).

• Collaborates with other quality professionals within R&D to support the QMS continuous improvement cycle (Plan, Do, Check, Act), including Deviation Management/ Corrective and Preventative Actions (CAPA).

• Supports a robust regulatory intelligence system by enabling the monitoring of changing regulations and ensuring that the BPO network incorporates changes efficiently and on time.

Win

What we expect of you

We are different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills and has these qualifications:

Basic Qualifications:

• Doctorate degree and 2 years of quality experience OR

• Master’s degree and 6 years of quality experience OR

• Bachelor’s degree and 8 quality experience OR

• Associate’s degree and 10 years of quality experience OR

• High school diploma / GED and 12 years of quality experience

In addition