Associate Vice President, Quality

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity and obesity-related conditions.

As a member of the Amgen team youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Associate Vice President Quality

What you will do

Lets do this. Lets change the this vital role as Associate Vice President Quality you will report to the Vice President Research and Development Quality (RDQ) Organization (a team of 30-40 staff will be built to serve Amgens Research Development Organization).

The Associate Vice President Quality will lead and provide proactive end to end quality strategies globally for therapeutic areas: Oncology Inflammation Cardiovascular Neuroscience and others. This role will drive the transformation of clinical quality oversight in compliance with ICH E6R3 and enable embedded quality oversight into clinical development teams. Incorporate quality by design principles to ensure quality risk management is identified and mitigated early to drive a high degree of compliance throughout the study conduct. Deliver inspection strategies to ensure successful submissions globally.

This role builds collaborative supportive relationships and serves as single point of accountability representing RDQ with the Amgen clinical research clinical operations regulatory and other relevant stakeholders in Research and Development (R&D) and Operations Quality in support of the therapeutic area for which they are responsible.

Responsibilities

• Ensures proper quality oversight strategies of research activities and RBQM in clinical trials.

• Lead a global team and manage all trials across the Amgen portfolio globally.

• RDQ has a key role and responsibility in driving embedded quality partnerships across critical R&D programs.

• RDQ has a key role in advancing data driven oversight capability across the organization.

• Responsible for inspection readiness inspection execution and follow up.

Clinical

• Expanding our capabilities beyond GCP compliance and audit mindset focus include:

  • Biosimilars

  • Rare Disease

  • Precision Medicine

  • Digital technology

  • Labelling

  • Product Complaint/Safety Reporting

  • PASS Study Management

  • Clinical trial simplification

  • Data analytics

  • Metrics development

  • R&D activities in response to regulatory trends and external pressures

• Quality and compliance oversight over Amgen General Medicine: cardiovascular obesity; Oncology Inflammation and Biosimilar Portfolios

• RDQ is transforming into an organization that provides quality assurance through proactive quality oversight in clinical trials on quality by design critical to quality measures and risk-based quality assurance.

• Oversight of FSP and ensures performance of vendors is adequately executed for each study.

• Leads health authority inspection readiness and inspection strategy for clinical globally.

Research

• Expanding our capabilities beyond GLP compliance mindset to include:

  • In-Vitro and Companion Diagnostics

    • Biomarkers

    • Lab services

    • Digital technology

    • Data analytics

• Research studies internally and externally sourced.

• Research vendors including innovative technology vendors lab facilities.

• Animal welfare.

• Health authority inspection readiness and inspection strategy for research

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The executive we seek is an experienced leader with the following qualifications.

Basic Qualifications:

• Doctorate degree and 7 years of Clinical & Research Quality experience OR

• Masters degree and 10 years of Clinical Quality experience OR

• Bachelors degree and 12 years of Clinical Quality experience AND

• 7 years of managerial experience directly leading people in a multi-tiered organization and/or leadership experience leading teams projects programs or directing the allocation of resources

Preferred Qualifications:

• Experience leading a Clinical Quality Assurance Team with oversight responsibilities of large clinical trial programs across multiple therapeutic areas.

• Experience delivering risk-based quality oversight programs in compliance with ICH guidelines and global regulatory requirements.

• Working knowledge of the legal and regulatory environment applicable laws regulations guidance and health authority expectations globally for drug development

• Proven track record in management and subsequent response to health authority inspections

They will also embody the Amgen leadership attributes which are:

• Inspire: Create a connected inclusive and inspiring work environment that empowers talent to thrive

• Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection

• Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients staff and shareholders

• Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

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 will support your journey every step of the way.

The expected annual salary range for this role in the U.S. is $266028 - $359920. 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:

• 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 and bi-annual company-wide shutdowns

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

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 with 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