Career Category
Quality
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 LEAD-OBSERVATIONAL RESEARCH LIVE What you will do This role will lead Safety and Medical Quality processes with a focus on Observational research activities. This role will be responsible for leading processes and activities related to the pharmacovigilance (GPvP) annual audit plan, the preparation and execution of audits, the investigation and monitoring of Quality events and supporting partner audits and regulatory inspections. The Quality Lead role in the Safety & Medical Quality organization will lead proactive identification of compliance issues relating to processes and programs, and escalation to compliance and quality oversight bodies, and participate in quality investigations, management, and remediation. Primary responsibilities: Plan, conduct and report on risk-based GPvP audits Assess and manage risks including providing input into the development of the annual GPvP audit plan. Provide Quality input for the risk assessment (CT-RACT) process relating to Observational research studies Act as the Quality Lead contact for vendor evaluation activities relating to observational research studies 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 Prepare, analyze, and communicate compliance metrics (e.g., audit and inspection data) and other significant compliance information. Maintain knowledge of current regulatory and compliance practices/issues, assess changes in regulations and the external environment, and advise customers. Support inspections and external audits, including preparing, conducting, and closing out response reviews. Provide support for audit planning meetings, debriefs, audit plan outlines and response reviews Improve R&D processes by contributing expertise in identifying robust Corrective and Preventive Action plans (CAPA). Develop long-term remediation's and process improvements through Root Cause Analysis (RCA). Key Competencies: Organizational Leadership Ability to Network Analytical Skills Decision Making Risk assessment and management Verbal and Written Communication Teamwork Time Management Interpersonal Skills Problem Identification and Resolution Ability to identify and implement process improvements Conflict Management This role requires up to 20% travel What we expect of you 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) Good working knowledge of global regulatory requirements for GPvP/ GCP and/or observational research Experience in training and mentoring GPvP auditors Experience with hosting partner audits/ regulatory inspections Experience and knowledge of requirements for computer systems audits Proven experience of working effectively in diverse teams Excellent time management skills and the ability to handle competing priorities Exceptional oral and written communication and writing skills. What you can expect of us 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 for a career that defies imagination Objects in your future are closer than they appear. Join us. 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.
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Quality
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 LEAD-OBSERVATIONAL RESEARCH LIVE What you will do This role will lead Safety and Medical Quality processes with a focus on Observational research activities. This role will be responsible for leading processes and activities related to the pharmacovigilance (GPvP) annual audit plan, the preparation and execution of audits, the investigation and monitoring of Quality events and supporting partner audits and regulatory inspections. The Quality Lead role in the Safety & Medical Quality organization will lead proactive identification of compliance issues relating to processes and programs, and escalation to compliance and quality oversight bodies, and participate in quality investigations, management, and remediation. Primary responsibilities: Plan, conduct and report on risk-based GPvP audits Assess and manage risks including providing input into the development of the annual GPvP audit plan. Provide Quality input for the risk assessment (CT-RACT) process relating to Observational research studies Act as the Quality Lead contact for vendor evaluation activities relating to observational research studies 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 Prepare, analyze, and communicate compliance metrics (e.g., audit and inspection data) and other significant compliance information. Maintain knowledge of current regulatory and compliance practices/issues, assess changes in regulations and the external environment, and advise customers. Support inspections and external audits, including preparing, conducting, and closing out response reviews. Provide support for audit planning meetings, debriefs, audit plan outlines and response reviews Improve R&D processes by contributing expertise in identifying robust Corrective and Preventive Action plans (CAPA). Develop long-term remediation's and process improvements through Root Cause Analysis (RCA). Key Competencies: Organizational Leadership Ability to Network Analytical Skills Decision Making Risk assessment and management Verbal and Written Communication Teamwork Time Management Interpersonal Skills Problem Identification and Resolution Ability to identify and implement process improvements Conflict Management This role requires up to 20% travel What we expect of you 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) Good working knowledge of global regulatory requirements for GPvP/ GCP and/or observational research Experience in training and mentoring GPvP auditors Experience with hosting partner audits/ regulatory inspections Experience and knowledge of requirements for computer systems audits Proven experience of working effectively in diverse teams Excellent time management skills and the ability to handle competing priorities Exceptional oral and written communication and writing skills. What you can expect of us 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 for a career that defies imagination Objects in your future are closer than they appear. Join us. 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.
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