Amgen Inc. (IR)
Safety and Medical Quality Lead-Observational Research
Amgen Inc. (IR), Hartford, Connecticut, United States,
Safety and Medical Quality Lead-Observational Research
Apply remote type Flex Commuter / Hybrid locations United Kingdom - Uxbridge United Kingdom - Remote United Kingdom - Cambridge time type Full time posted on Posted 2 Days Ago job requisition id R-201431
Career Category Clinical
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
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
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
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.
#J-18808-Ljbffr
Career Category Clinical
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
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
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
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.
#J-18808-Ljbffr