Biotechnology Safety and Medical Quality Lead

1 week ago


Hartford, Connecticut, United States Amgen Full time

About the Role
As a Biotechnology Safety and Medical Quality Lead, you will be responsible for identifying and escalating compliance issues to oversight bodies, participating in quality investigations, management, and remediation. This role focuses on Safety and Medical processes, particularly Observational research activities.

Key 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).

About Amgen
Amgen is a leading biotechnology company that serves patients worldwide with innovative products. As a part of our Global R&D Quality organization, you will work closely with a diverse international team to strengthen and enhance the R&D Quality Management System.

What We Offer
• Estimated salary: £90,000 - £110,000 per year (dependent on experience)
• Flexible remote work options, or flexible hybrid work arrangement near our offices in Cambridge or Uxbridge
• 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, wealth, work-life balance, and career benefits

Requirements
• Degree educated
• Proven experience in R&D, Operations, and/or Quality 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 ability to handle competing priorities
• Exceptional oral and written communication and writing skills



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