Safety and Medical Quality Manager - Observational Research

Career Category

Job Description

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

SAFETY AND MEDICAL QUALITY MANAGER - OBSERVATIONAL RESEARCH

LIVE

What you will do

The Quality Manager in the Safety & Medical Quality organisation will identify compliance issues participate in audits, quality investigations and remediation activities.

This role supports Safety and Medical processes, with a focus on Observational research activities. Key responsibilities include supporting the pharmacovigilance (GPvP) annual audit plan, preparing and completing audits, investigating Quality events, and assisting with partner audits and regulatory inspections.

Primary responsibilities:

• Plan, conduct and report on risk-based R&D audits

• Support the completion of the audit plan for GPvP suppliers/vendors and processes

• Support investigations of deviations from GPvP and GCP processes including root cause analysis, design, development or Corrective and Preventive Actions (CAPAs) and Effectiveness Verifications (EVs)

• Update records in the digital quality management system (DQMS) and track through to closure

• Collating and verifying objective evidence for inspection & audit driven CAPAs/EVs

• Data entry into the risk assessment tool (using risk assessment methodology)

• Support GxP audits from business partners, GxP inspection readiness and inspection management activities

• Support R&D Quality governance in clinical development, pharmacovigilance and/or observational research

• Assist with audit planning meetings, debriefs, audit plan outlines and response reviews

• Maintain knowledge of current regulatory and quality practices/issues

• Collate compliance metrics for presentations to key stakeholders

• Support vendor evaluations related to observational research studies and GPvP or GCP vendors

• Actively seek and implement innovative quality oversight methodologies to improve our processes (e.g. risk-methods using AI and Natural Language Processing, and data analytics)

JOIN OUR TEAM

The Safety and Medical Quality team is a diverse international team within the Global R&D Quality organisation. We are in charge of strengthening and enhancing the R&D Quality Management System, providing Quality oversight on R&D processes, and leading activities related to PV regulatory inspections and audits of the Amgen PV system.

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

• Degree Educated

• Proven experience in the Pharma/Biotech sector

• Experience as an auditor, preferably in Good Pharmacovigilance Practice (GPvP) or Good Clinical Practice (GCP)

• Solid understanding of global regulatory requirements for GPvP/GCP/ observational research

• Experience in supporting GPvP/GCP audits or inspections

• Outstanding oral and written communication skills.

• Some knowledge of statistical programming tools, such as STATA or SAS would be a plus

THRIVE

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

LOCATION: Ability to work fully remote, or, if situated near an office, the option to work flexibly from home with occasional office presence at our Cambridge or Uxbridge next-generation workspace.

APPLY NOW

What we do is hard. It should be. We are working with each other against the challenges of today for the promise of tomorrow. Lead the way.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.