Safety and Medical Quality Lead-Observational Research

Career Category

Job Description

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. 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

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 and 2 years of R&D, Operations, and/or Quality experience in the PhRMA/Biotech sector or equivalent experience OR

• Master’s degree and 6 years of R&D, Operations, and/or Quality experience in the PhRMA/Biotech sector or equivalent experience OR

• Bachelor’s degree and 8 years of R&D, Operations, and/or Quality experience in the PhRMA/Biotech sector or equivalent experience OR

• Associate’s degree and 10 years of R&D, Operations, and/or Quality experience in the PhRMA/Biotech sector or equivalent experience OR

• High school diploma / GED and 12 years of R&D, Operations, and/or Quality experience in the PhRMA/Biotech sector or equivalent experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years 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:

• Five plus years’ experience with auditing, in Good Pharmacovigilance Practice (GPvP)

• 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

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.

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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.

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