Amgen
Safety and Medical Quality Lead-Observational Research
Amgen, Washington, District of Columbia, us, 20022
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Safety and Medical Quality Lead - Observational Research What you will do
Let’s do this! Let’s change the world! 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.
The Quality Lead role in the Safety & Medical Quality organization will support 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.
This role will support Safety and Medical processes with a focus on Observational research activities. The role will be responsible for supporting 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.
Primary Responsibilities
Plan, conduct and report on risk-based R&D audits
Support the execution of the audit plan for GPvP suppliers/vendors and processes.
Support investigations of deviations from GPvP and GCP processes including execution of root cause analysis, design, development or Corrective and Preventive Actions (CAPAs) and Effectiveness Verifications (EVs).
Entering and updating records in the digital quality management system (DQMS) based on investigation and deviation meetings and tracking 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 Safety and Global Development teams in GxP audits from business partners. GxP inspection readiness and inspection management activities.
Support R&D Quality governance bodies in the clinical development, pharmacovigilance and/or observational research areas.
Provide support for audit planning meetings, debriefs, audit plan outlines and response reviews
Maintain knowledge of current regulatory and quality practices/issues
Collate compliance metrics (e.g. audit/inspection data and other significant compliance information) to support presentations to key partners.
Support vendor evaluations related to observational research studies and GPvP or GCP vendors
Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods).
Key Competency
Verbal and Written Communication
Teamwork
Time Management
Interpersonal Skills
Analytical Skills
Problem Identification and Resolution
Ability to identify and implement process improvements
Diversity Awareness
Conflict Management
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree OR
Master’s degree and 3 years of quality experience OR
Bachelor’s degree and 5 years of quality experience OR
Associate’s degree and 10 years of quality experience OR
High school diploma / GED and 12 years of quality experience
In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.
Preferred Qualifications:
Bachelor of Science degree in appropriate discipline or equivalent (required)
Minimum of 4 years in biopharmaceutical industry
Minimum of 2 years R&D, Operations and/or Quality experience in the PhRMA/Biotech sector or equivalent
Experience as an auditor, preferably in Good Pharmacovigilance Practice (GPvP) or Good Clinical Practice (GCP)
Good working knowledge of global regulatory requirements for GPvP/GCP/ observational research
Experience in GPvP/GCP audits and inspections
Exceptional oral and written communication and writing skills.
Statistical programming, such as STATA or SAS
What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now
for a career that defies imagination. Objects in your future are closer than they appear. Join us.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided 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 accommodation.
#J-18808-Ljbffr
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Safety and Medical Quality Lead - Observational Research What you will do
Let’s do this! Let’s change the world! 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.
The Quality Lead role in the Safety & Medical Quality organization will support 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.
This role will support Safety and Medical processes with a focus on Observational research activities. The role will be responsible for supporting 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.
Primary Responsibilities
Plan, conduct and report on risk-based R&D audits
Support the execution of the audit plan for GPvP suppliers/vendors and processes.
Support investigations of deviations from GPvP and GCP processes including execution of root cause analysis, design, development or Corrective and Preventive Actions (CAPAs) and Effectiveness Verifications (EVs).
Entering and updating records in the digital quality management system (DQMS) based on investigation and deviation meetings and tracking 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 Safety and Global Development teams in GxP audits from business partners. GxP inspection readiness and inspection management activities.
Support R&D Quality governance bodies in the clinical development, pharmacovigilance and/or observational research areas.
Provide support for audit planning meetings, debriefs, audit plan outlines and response reviews
Maintain knowledge of current regulatory and quality practices/issues
Collate compliance metrics (e.g. audit/inspection data and other significant compliance information) to support presentations to key partners.
Support vendor evaluations related to observational research studies and GPvP or GCP vendors
Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods).
Key Competency
Verbal and Written Communication
Teamwork
Time Management
Interpersonal Skills
Analytical Skills
Problem Identification and Resolution
Ability to identify and implement process improvements
Diversity Awareness
Conflict Management
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree OR
Master’s degree and 3 years of quality experience OR
Bachelor’s degree and 5 years of quality experience OR
Associate’s degree and 10 years of quality experience OR
High school diploma / GED and 12 years of quality experience
In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.
Preferred Qualifications:
Bachelor of Science degree in appropriate discipline or equivalent (required)
Minimum of 4 years in biopharmaceutical industry
Minimum of 2 years R&D, Operations and/or Quality experience in the PhRMA/Biotech sector or equivalent
Experience as an auditor, preferably in Good Pharmacovigilance Practice (GPvP) or Good Clinical Practice (GCP)
Good working knowledge of global regulatory requirements for GPvP/GCP/ observational research
Experience in GPvP/GCP audits and inspections
Exceptional oral and written communication and writing skills.
Statistical programming, such as STATA or SAS
What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now
for a career that defies imagination. Objects in your future are closer than they appear. Join us.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided 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 accommodation.
#J-18808-Ljbffr