Quality Compliance Manager

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

What You Will Do

The Quality Compliance Manager is a global role and part of the Safety & Medical Quality (SMQ) team for the R&D Quality Organization.

SMQ Team at Amgen implements the global R&D Quality strategy across R&D and other functional areas requiring pharmacovigilance (PV) oversight. The team monitors the audit universe to identify compliance risks, which inform PV audit program development. They lead or support inspection readiness and management, communicate audit and inspection outcomes to stakeholders, and advise on remediation. Additionally, the SMQ Team partners with stakeholders to provide compliance guidance, highlight trends and risks from various data sources to drive process improvement, and participates in service provider governance and due diligence activities.

In this vital role, the Quality Compliance Manager will ensure excellence in R&D Quality processes is maintained through oversight and improvements when compliance issues are identified. They will be an integral team member working globally with Business Process Owners to ensure compliance with GPvP regulations and other business requirements including the Global Safety database and associated systems. Additionally, the Quality Compliance Manager will provide proactive end to end quality support for the management of Quality Incidents/Quality Events, working closely with Quality Leads in approving investigations, including root cause analysis (RCA) and Corrective & Preventive Action (CAPA) plans.

Roles & Responsibilities:

The Quality Compliance Manager will work both independently and in a team environment to foster collaborative relationships within R&D Quality. In this dynamic role, they will be responsible for supporting processes and operational activities related to overseeing Good Pharmacovigilance Practice (GPvP) deviations, preparation of audits and inspections across R&D Quality. As part of strengthening and advancing Amgen’s R&D QMS, this role provides end-to-end quality support to deviation owners, RCA owners, and CAPA owners within Global Patient Safety and other parts of the organization.

• Supports the intake, triage, and categorization of deviations, ensuring appropriate classification and documentation.
• Facilitates timely and thorough deviation investigations in collaboration with functional area representatives and Quality Leads
• Ensures consistent and compliant documentation of deviation records within the electronic quality management system (DQMS).
• Monitors and ensures adherence to timelines, escalating delays and risks as needed.
• Supports Global Patient Safety and Global Development teams in GxP inspection management activities and GxP audits from business partners
• Identifies, leads, or contributes to continuous improvement initiatives to enhance CAPA management practices.
• Collaborates with cross-functional partners to ensure processes remain effective, efficient, and aligned with industry best practices and evolving regulations.
• Ensures the integrity, traceability, and quality of deviation and CAPA records in compliance with ALCOA+ principles.
• Monitors quality metrics and key performance indicators (KPIs) related to deviation and CAPA management.
• Analyses trends and perform root cause trending to identify systemic issues and opportunities for process improvement.
• Manages, organizes and analyses data through different systems, tools, or platforms, including Excel and Smartsheet
• Maintains knowledge of current regulatory and quality practices/issues
• Maintains the Global R&D CRQ and SMQ SharePoint sites
• Manages the appropriate archival and retention of audit documentation.
  
  

What We Expect Of You

Basic Qualifications and Experience:

• Master’s degree and 8-13 years in Pharma and Biotechnology R&D Quality
  
  

Additional Competencies/Skills:

• Comprehensive expertise in Good Pharmacovigilance Practices (GPvP), with a strong command of operational standards and the quality frameworks governing drug safety.
• Understand of regulatory requirements: Knowledge of global PV regulations (e.g., EMA GVP Modules, ICH E2E/E2F, FDA safety guidelines, MHRA expectations).
• Solid understanding of end-to-end case management workflows, including upstream and downstream activities, and the related systems such as global safety databases (e.g., Argus, ArisG).
• Demonstrated ability to leverage artificial intelligence (AI) tools and technologies to streamline workflows, drive process automation, and support data-driven decision-making. Must be adept at identifying opportunities to apply AI for operational efficiency and continuous improvement initiatives.
• Proficiency in operating Quality Management Systems (QMS), particularly TrackWise and Veeva QMS, to manage quality events, documentation, and compliance workflows.
• 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 team building skills and the ability to on-board new employees and develop them over time
• Familiarity with project management tools and methodologies.
• Experience working in a multinational environment with global teams.
• 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