Quality Compliance Senior Manager

HOW MIGHT YOU DEFY IMAGINATION

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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 Senior Manager is a global role and part of the Clinical & Research Quality (CRQ) team for the R&D Quality Organization.

CRQ organization plays a critical role in ensuring that our research and development activities are conducted in an ethical and responsible manner CRQ is responsible for ensuring that our research and development activities meet the highest standards of quality and compliance, ultimately keeping patients safe, protecting their welfare, while ensuring that all data produced has integrity.

In this vital role , the Quality Compliance Senior Manager will contribute to providing leadership to ensure excellence in R&D Quality Processes is maintained through oversight and improvements when compliance issues are identified In addition, this role will serve as a mentor for Amgen staff in India who will be working to advance the Quality System, and they will act to manage day to day activities for the team. They will be an integral team member working globally with Business Process Owners to ensure compliance with regulations and other business requirements. This role will be part of supporting the digital quality management system (DQMS) as a Subject Matter Expert SME ) to support the core processes managed in Quality. Additionally, the Quality Compliance Senior 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 C orrective & Preventive Action (C APA ) plans.

Roles & Responsibilities:

The Quality Compliance Senior Manager will work both independently and in a team environment to foster collaborative relationships with in R&D Quality. In this vital role , they will be responsible for supporting processes and operational activities related to ; overseeing deviations, preparation of audits and inspections across R&D Quality including Good Pharmacovigilance Practice ( GPvP ), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). As part of strengthening and advancing Amgens R&D QMS, this role provides end-to-end quality support to Deviation owners, RCA owners, and CAPA owners.

• Manages the Amgen India R&D Quality team to ensure that the team is supported and managed on a day-to-day basis.

• Support s the intake, triage, and categorization of deviations, ensuring appropriate classification and documentation.

• Facilitate s timely and thorough deviation investigations in collaboration with functional area r epresentatives and Quality Leads.

• E nsure s consistent and compliant documentation of deviation records within the electronic quality management system ( D QMS).

• Monitor s and ensure s adherence to timelines, escalating delays and risks as needed.

• Support s Global Patient Safety and Global Development teams in GxP inspection management activities and GxP audits from business partners

• Identif ies , lead s , or contribute s to continuous improvement initiatives to enhance CAPA management practices.

• Collaborate s with cross-functional partners to ensure processes remain effective, efficient, and aligned with industry best practices and evolving regulations.

• Ensure s the integrity, traceability, and quality of deviation and CAPA records in compliance with ALCOA+ principles.

• Monitor s 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.

• Manage s , organize s and analyse s data through different systems, tools, or platforms, including Excel and Smartsheet

• Maintain s knowledge of current regulatory and quality practices/issues

• Maintain s the Global R&D CRQ and SMQ SharePoint sites

• Manage s the appropriate archival and retention of audit documentation.

What we expect of you

Basic Quali fi cations and Experience:

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

Additional Competencies/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 team building skills and the ability to on-board new employees and develop them over time

• Familiarity with project management tools and methodologies.

• Knowledge of GCP, GLP and/or GPvP .

• 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