Safety and Medical Quality Lead-Observational Research

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 LEAD-OBSERVATIONAL RESEARCH

LIVE

What you will do

In this vital role the Quality Lead in the Safety & Medical Quality organization will identify and escalate compliance issues to oversight bodies, participate in quality investigations, management, and remediation. This role focuses on Safety and Medical processes, particularly Observational research activities. Responsibilities include leading the pharmacovigilance (GPvP) annual audit plan, preparing and completing audits, investigating and supervising Quality events, and supporting partner audits and regulatory inspections.

Primary responsibilities

• Provide Quality input for processes relating to Observational research studies (e.g., the clinical trial risk assessment [CT-RACT])

• Participate as the Quality representative for evaluating, qualifying, and providing oversight of Pharmacovigilance vendors.

• Participate in due diligence activities for potential business development opportunities.

• Ensure proactive identification of issues relating to processes, programs, and external relationships, escalate issues to appropriate compliance/quality oversight bodies and participate in compliance investigations, management, and remediation

• Assess and manage risks including providing input into the development of the annual GPvP audit plan.

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

• Prepare and communicate compliance metrics (e.g., audit and inspection data)

• Stay updated on regulatory and compliance practices and advise stakeholders

• Triage and/or manage R&D/ Pharmacovigilance Publications compliance matters

• Support inspections and audit plannings

• Contribute to Continuous Improvement Initiatives

• Improve R&D processes by giving expertise in identifying robust Corrective and Preventive Action plans (CAPAs).

• Develop long-term remediations and process improvements through Root Cause Analysis (RCAs).

BE PART OF OUR TEAM

The Safety and Medical Quality team is a diverse international team within the Global R&D Quality organization. We are responsible for 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 external 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 R&D, Operations and/or Quality experience in the Pharma/Biotech sector

• Demonstrated leadership expertise in developing teams, coordinating projects or programs, and advising resource allocation

• Proven track record with auditing, preferably in Good Pharmacovigilance Practice (GPvP) or Good Clinical Practice (GCP) and knowledge of global regulatory requirements

• Some knowledge of statistical programming used with observational research, such as STATA or SAS

• Experience and knowledge of requirements for computer systems audits

• Excellent time management skills and the ability to handle competing priorities

• Exceptional oral and written communication and writing skills.

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.

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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.