manager, r&d process quality

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.

MANAGER, R&D PROCESS QUALITY

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 implement 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 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 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

• Supports Amgen's procedural framework so that all procedures maintain compliance to relevant laws, regulations, and internal quality standards; works to ensure that procedures maintain the ethical and safe treatment of all research subjects and that all data has integrity.

• Ensures that all procedures are written clearly for the execution of Amgen's research tasks within a diverse, complex, and cross-functional team of researchers.

• Supports the change control of business procedures in a timely manner with a focus on detail and the output of concisely written documentation.

• Supports incoming procedural change requests, including the assessment of changes (impact to the QMS, including traceability of changes across other document sets.

• Supports the work of Business Process Owners and applies risk-based strategies consistently to identify and mitigate risks towards the continuous advancement of Amgen's R&D QMS.

• Applies industry standard processes for optimal (standardized and lean) procedural documentation, and the use of technology to drive an efficient and effective knowledge management system.

• Supports the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network in order to enable Management Reviews (periodic review by management to ensure QMS health is maintained).

• Collaborates 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 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 AND

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:

• Experience within Biotech/pharmaceutical Research, including the application of Global Regulations.

• Direct experience working with standard procedural documentation, including their creation, change control (requests for change and the execution of changes.

• Solid understanding of SOP/Standards management, and methods/ technology used to drive knowledge management across a diverse R&D environment.

• Strong Process Mind and analytically oriented - experience with process monitoring, including the application of analytical methods and modern technology used to enable signal detection and quality improvement.

• Proven team player – takes direction and is able to rapidly learn and support a hard-working team and is able to make rapid decisions and communicate them in a timely manner.

• 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 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 and make a lasting impact with the Amgen team.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.