Director, R&D Process Quality Business Intelligence & Data Analytics

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.

Director, R&D Process Quality Business Intelligence & Data Analytics

What you will do

Let’s do this! Let’s change the world! In this vital role you will work with a team of process-focused colleagues who work to execute Amgen’s Process Quality strategy, which is vital to ensuring that Amgen’s Research and Development Standards (SOPs and associated documentation) are adequate, clear, and up to all applicable current regulations and quality requirements. The Director of Business Intelligence & Data Analytics (BIDA) develops and implements a proactive, end to end, risk-based quality improvement strategy. Focusing on the analysis of Quality System data and the generation of quality metrics to help Amgen’s QMS function effectively and efficiently, while improving continuously as driven by the quality data.

The R&D Process Quality team supports the Quality Management System (QMS) across all areas of research at Amgen, including discovery through the full clinical development lifecycle. This team ensures that all Amgen’s business procedures meet internal and external quality standards and are managed for optimum efficiency and effectiveness. The Process Quality team also ensures that Amgen’s R&D Business Process Network develops and manages fit for purpose standards (SOPs) that are continuously improved upon using quality by design (QbD), and risk management methods that include QMS analytics showing quality signals and trends.

Responsibilities

• Provide systematic and strategic methods to assess and measure Quality as a competitive advantage for Amgen R&D.

• Provide strategic leadership in developing and implementing systematic methods to measure and improve R&D quality, ensuring alignment of all data analytics and business intelligence initiatives with broader organizational goals and evolving regulatory requirements.

• Ensure People, Processes, Systems, Data Analytics and Innovation are used effectively to move Quality Culture towards a proactive predict and prevent culture.

• Effectively lead, collaborate and partner with internal R&D team members to analyze and resolve issues and risks to drive clear scope, sponsorship, planning and execution.

• Lead and support management directed data driven projects that are of large impact/scope and thus risk for Amgen clinical trials and pre-clinical research activities.

• Support Amgen’s procedural framework through the development, maintenance, and communication of procedural performance measures/indicators; ensure that all procedures maintain compliance to relevant laws, regulations, and internal quality standards; so that Amgen treats all research subjects ethically and safely, and all data is generated with full integrity.

• Ensure that all of Amgen’s research procedures are properly measured for performance and that key partners, including management, are informed regularly; work to support the management review system within the Amgen QMS through timely generation of reports and tracking of key actions.

• Support the procedural change process through the communication of metrics designed in collaboration with the Business Process Owner network and leadership across R&D functional areas.

• Collaborate with Business Process Owners and apply risk-based strategies consistently to identify and mitigate risks towards the continuous advancement of Amgen’s R&D QMS.

• Lead the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network to support periodic review by management to ensure maintenance of QMS health.

• Collaborate with other quality professionals within R&D to support the QMS continuous improvement cycle (Plan, Do, Check, Act), including Deviation Management/ Corrective and Preventative Actions (CAPA).

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, and has these qualifications.

Basic Qualifications:

• Doctorate degree and 4 years of quality experience OR

• Master’s degree and 8 years of quality experience OR

• Bachelor’s degree and 10 years of quality experience

In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and 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:

• 15 years or more experience in Quality Management, Quality Assurance, Continuous Improvement, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.

• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Trackwise.

• Thorough understanding of Clinical R&D activities and Global Regulations.

• Well versed in the development of quality measures including their creation and usage in a complex, cross-functional/matrixed environment.

• Strong analytical capabilities - experience with process monitoring, including the application of advanced analytical methods and modern technology used to enable signal detection and quality improvement (e.g., Spotfire, PowerBI, Python).

• Innovative spirit, willing to challenge the status quo - enables process owners to understand what is working well and what needs to be evaluated and/or changed.

• Knowledge of the Regulatory Submission and Inspection Management procedures.

• People leadership and managerial expertise.

• Collaborative and flexible – able to work in ambiguity while defining standards that work to motivate and drive and demonstrate continuous improvement.

• Proven team player – takes direction and can rapidly learn and support a hard-working team and can make rapid decisions and communicate them in a timely manner to team members within other functional areas.

• Excellent verbal and written communication skills - demonstrates strong business writing abilities and active listening.

• Capability to understand and articulate technical concepts and literature in spoken and written English.

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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