Associate Vice President, Quality
Amgen
This listing was originally posted on Amgen's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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Upgrade to Pro — $25/moJoin 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. 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, 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.
Associate Vice President, Quality
What you will do
Let’s do this. Let’s change the world. In 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 Amgen’s 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
Master’s degree and 10 years of Clinical Quality experience OR
Bachelor’s 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 $266,028 - $359,920. 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
266,027.90USD -359,920.10 USDExplore related positions you might be interested in
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