Manager, R&D Process Quality

What you will do

Lets do this! Lets change the world! In this vital role you will work with a team of process-focused colleagues who work to implement Amgens Process Quality strategy, which is vital to ensuring that Amgens Research and Development Standards (SOPs and associated documentation) are adequate, clear, and up to all applicable current regulations and quality requirements.

The R&D Process Quality team supports the Quality Management System (QMS) across all areas of research at Amgen, including discovery through the full clinical development lifecycle. This team ensures that all Amgen business procedures meet internal and external quality standards and are managed for optimum efficiency and effectiveness. The Process Quality team also ensures that Amgens 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 that include QMS analytics showing quality signals and trends.

Responsibilities

• Supports Amgens procedural framework so that all procedures maintain compliance to relevant laws, regulations, and internal quality standards; works to ensure that procedures maintain the ethical and safe treatment of all research subjects and that all data has integrity.
• Ensures that all procedures are written clearly for the execution of Amgens research tasks within a diverse, complex, and cross-functional team of researchers.
• Supports the change control of business procedures in a timely manner with a focus on detail and the output of concisely written documentation.
• Supports incoming procedural change requests, including the assessment of changes (impact to the QMS, including traceability of changes across other document sets.
• Supports the work of Business Process Owners and applies risk-based strategies consistently to identify and mitigate risks towards the continuous advancement of Amgens R&D QMS.
• Applies industry standard processes for optimal (standardized and lean) procedural documentation, and the use of technology to drive an efficient and effective knowledge management system.
• Supports the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network in order to enable Management Reviews (periodic review by management to ensure QMS health is maintained).
• 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).

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 3 years of quality experience OR
• Bachelors degree and 5 years of quality experience OR
• Associates degree and 10 years of quality experience OR
• High school diploma / GED and 12 years of quality experience AND

In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• Experience within Biotech/pharmaceutical Research, including the application of Global Regulations.
• Direct experience working with standard procedural documentation, including their creation, change control (requests for change and the execution of changes.
• Solid understanding of SOP/Standards management, and methods/ technology used to drive knowledge management across a diverse R&D environment.
• Strong Process Mind and analytically oriented - experience with process monitoring, including the application of analytical methods and modern technology used to enable signal detection and quality improvement.
• Proven team player takes direction and is able to rapidly learn and support a hard-working team and is able to make rapid decisions and communicate them in a timely manner.
• Excellent verbal and written communication skills - demonstrates strong business writing abilities and active listening.
• Capability to understand and articulate technical concepts and literature in spoken and written English.