GCP Quality Compliance Manager

What you will do

The Quality Compliance Manager is a global role and part of the Process Quality team for the RD Quality Organization.

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

The RD 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 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 RD 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. In addition, this individual will help support end users in RD with the digital quality management system (DQMS) with queries, deviations and Corrective and Preventive Actions (CAPAs).

The Quality Compliance Manager will contribute to implementing strategies and providing leadership to ensure excellence in RD Quality Processes. As an integral team member working globally with Business Process Owners to ensure compliance with regulations and other requirements.

Roles Responsibilities:

This role will work both independently and in a team environment. Their primary responsibility is to support continuous improvement initiatives for RD quality, but they will also be responsible for any other operational or strategy activities assigned.

• Generate and review process area Knowledge Maps (spider maps, lessons learning, and data processing techniques, stored in a graph-based database for better search, analysis, and visualization) to help determine inherent and residual risks, document risk assessments, and collaborate with Business Process Owners and Quality Leads to ensure accurate risk classification and preventive actions.
• Supports Amgen s 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.
• Provide real-time, site-level quality oversight using analytical tools to identify trends, weaknesses, and data quality issues.
• Perform focused quality control checks on-site and remotely at clinical trial locations, especially key target sites.
• Offer independent and objective quality advice to local study teams
• Conduct risk assessments to inform audit site selection and pre-inspection/mock inspection visits.
• Support site/sponsor inspection readiness and management, including prep, conduct, response, and close-out phases.
• Ensures that all procedures are written clearly for the execution of Amgen s research tasks within a diverse, complex, and cross-functional team of researchers.
• 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 Amgen s RD QMS.
• 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.
• 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 RD to support the QMS continuous improvement cycle (Plan, Do, Check, Act), including Deviation Management/ Corrective and Preventative Actions (CAPA).

What we expect of you

Basic Qualifications and Experience:

• Master s degree and 4-6 years in Pharma and Biotechnology RD Quality OR
• Bachelor s degree and 6-8 years of years in Pharma and Biotechnology RD Quality.
• Diplomas degree and 10-12 years of years in Pharma and Biotechnology RD Quality.

Functional Skills:

Must-Have Skills:

• Exceptional attention to detail and accuracy in all deliverables.
• Ability to work independently and proactively in a fast-paced environment.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e. g. , Teams, WebEx)
• Solid understanding of SOP/Standards management, and methods/ technology used to drive knowledge management across a diverse RD environment.

Good-to-Have Skills:

• Familiarity with project management tools and methodologies.
• Knowledge of GCP, GLP and/or GPvP.
• Experience working in a multinational environment with global teams.
• 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.

Soft Skills:

• Excellent verbal and written communication skills.
• High degree of professionalism and interpersonal skills.
• Strong problem-solving abilities and adaptability to changing priorities.
• Collaborative attitude and ability to build positive relationships across diverse teams.
• Resilience, discretion, and the ability to thrive under pressure

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.
• In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.