Career Category
Operations
Job Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Senior Director, In-Vitro Diagnostics/Precision Medicine Lead
Live
What you will do
Job Description
Let’s do this! Let’s change the world! In this vital role you will report to the Associate Vice President, R&D Quality (RDQ), and be responsible for a team of approximately 5-10 colleagues. The Senior Director, In-Vitro Diagnostics/ Precision Medicine Lead provides quality leadership for a team specifically focused on Amgen’s development and use of In-Vitro Diagnostics (IVD), including Companion Diagnostics (CdX), and Precision Medicine applications to clinical development. This role is responsible for the development and implementation of an end to end, proactive and risk-based Quality Assurance strategy for IVD, and Precision Medicine, including third-party collaborations.
The In-Vitro Diagnostics/ Precision Medicine Quality strategy is focused on all aspects of research and development at Amgen, spanning from discovery through the entire lifecycle of clinical development. This strategy will ensure that all Amgen’s business procedures meet internal and external quality standards, and that they are managed for optimum efficiency and effectiveness. The In-Vitro Diagnostics/ Precision Medicine Quality strategy also ensures that the business develops and manages fit for purpose standards (SOPs and quality agreements). In addition, the strategy will ensure that Amgen’s QMS is continuously improved upon using quality by design, risk assessments, and outputs from the Quality Management System, including analytics showing quality trends and potential continuous improvement opportunities.
Responsibilities
- Develop collaborative partnerships with Research and Development (R&D) Leadership to define the state of quality and potential areas of quality risk exposure. Develop innovative methods for improving the quality oversight for Amgen’s IVD and Precision Medicine programs.
- Provide quality leadership in a cross-matrixed environment and ensure that Amgen’s R&D efforts, including partnerships and third parties, are aligned to industry standard processes and all regulations.
- Develop and implement IVD quality management strategies to ensure compliance to an evolving and complex IVDR regulatory landscape, particularly in the European Union.
- Partner with the RDQLT and key stakeholders to develop metrics (KQI, KPI leading and lagging) related to IVD and Precision Medicine.
- Coordinate and collaborate with clinical trial teams to ensure that all respective critical to quality components are incorporated into clinical trial design, execution and support of regulatory filings.
- Maintain up-to-date knowledge of IVD regulations and applicable guidance; monitor development of regulations and communicate impact to the business.
- Provides risk-based quality assurance and oversight for IVD/ Precision Medicine activities (e.g., auditing, deviation management and inspection management).
- Ensures that all applicable integrated procedures (e.g., acquired assets) are fit for purpose and aligned to Amgen’s standards.
- Oversee the management of QMS related to business procedures, including the development and execution of the process assessment and audit program (internal and external), and the management of Deviations/CAPA, and the support of Inspections by Health Authorities or certified bodies.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, with these qualifications:
Basic Qualifications:
Doctorate degree and 4 years of Quality Management, Quality Assurance, or other relevant experience
Or
Master’s degree and 8 years of Quality Management, Quality Assurance, or other relevant experience
Or
Bachelor’s degree and 10 years of Quality Management, Quality Assurance, or other relevant experience
In addition to meeting at least one of the above requirements, you must have a minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.
Preferred Qualifications:
- 5 years of managerial experience directly leading people in a multi-tiered organization with an ability to build a high performing team.
- 5 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry developing and implementing risk-based quality oversight/ management, and experience with medical device development and quality management.
- Oversight and implementation of Quality Management Systems, including electronic QMS such as Veeva or TrackWise (Sparta Systems).
- Deep knowledge of QMS related to IVD, medical device/combination products regulations, and Precision Medicine; implementation of technology to improve knowledge management across a diverse R&D environment.
- In depth understanding of Clinical Development in Precision Medicine
- Thorough understanding of Biotech/pharmaceutical Research activities and Global Regulations.
- Experience with compliance to all GxP requirements including the oversight of third-party vendors, suppliers, partners, audits, and inspections.
- Ability to transform business and customer feedback into clear, efficient processes using a straightforward language and format.
- Strong analytical, critical-thinking, and decision-making abilities, including development and implementation of Analytics methods and technology in order to enable signal detection and quality improvement.
- Excellent verbal and written communication skills, including strong business writing abilities and active listening.
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising 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 including:
- 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, including remote 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
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
211,721.00 USD - 233,975.00 USD
