Safety and Medical Quality Lead-Observational Research

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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

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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. 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 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.

Salary Range
105,924.00 USD - 135,934.00 USD