Quality Compliance Manager- Process Excellence, Continuous Improvement

Quality Compliance Manager Process Excellence, Continuous Improvement & Innovation

What you will do

l The Quality Compliance Manager is a global role and part of the Continuous Improvement & Innovation team for the R&D Quality Organization. This role will support processes and efforts related to continuous improvement and change management.

They will be a vital part of Amgen's Quality Management System, providing expert support to create and manage R&D controlled processes aimed at continuous improvement through the application of standard methodologies (Lean, DMAIC, Six Sigma).

The Quality Compliance Manager will contribute to implementing strategies and providing leadership to ensure excellence in R&D Quality Processes. As an integral team member working globally with Business Process Owners to ensure compliance with regulations and other requirements. This individual will be part of supporting the digital quality management system (DQMS) as an SME to support new and the core processes managed in Quality.

Roles & Responsibilities:

This role will work both independently and in a team environment to foster collaborative relationships with R&D and OCMO to assess the current state of quality, identify potential quality risks, and explore innovative strategies for enhancing the Quality Management System (QMS) in a fast-paced R&D setting. they will also be responsible for any innovative, process excellence strategy activities.

• Design, implement, and/or support proactive, comprehensive, risk-based quality improvement strategies for R&D, OCMO, and R&D Quality through established processes and methodologies (Lean, DMAIC, Six Sigma, Kaizen, Quality by Design, etc.).
• Supervise improvement initiatives for R&D Quality informed by insights from Amgen's quality system, including audits/inspection findings, deviations, and quality trend analyses.
• Serves as a cornerstone of quality and innovative approaches to enhance the QMS within an agile R&D environment.
• Lead Organizational Change Management (OCM) initiatives for projects spearheaded by R&D Quality.
• Provide input and technical expertise to establish, implement, maintain, and adapt continuous improvement methodologies, for example Six Sigma, Lean, Kaizen and ADKAR.
• Assist OCM strategies for initiatives driven by Operations and R&D/OCMO that may affect the R&D Quality Organization.
• Provide quality expertise and guidance to R&D functions and business process owners to ensure comprehensive, clear, and well-managed organizational changes
• Partner with process owners, training leadership, and business process management to implement robust communication strategies and training
• Manage, organize and analyze data through different systems, tools, or platforms, including Excel and Smartsheet

What we expect of you

Basic Qualifications and Experience:

• Masters degree with 4-6 years of Pharma and Biotech R&D or commercial manufacturing Quality experience. Continuous Improvement/Change Management experience is preferred
• Bachelors degree and 6-8 years of Pharma and Biotech R&D or commercial manufacturing Quality experience. Continuous Improvement/Change Management experience is preferred.

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 Smartsheet, Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams, WebEx)

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.

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