Director Monitoring Excellence Jobs (NOW HIRING)

Career CategoryQualityJob 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. 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.

Senior Director, Operational Excellence

What you will do

Let's do this! Let's change the world! The Senior Director of Operational Excellence will lead the strategy, governance, transformation, and execution of continuous improvement initiatives across the Research & Development (R&D) Quality organization. This leader will drive scalable, efficient, compliant, and data-driven processes that enhance quality oversight across GCP, GLP, GVP and research functions including clinical development, pharmacovigilance, laboratories, quality systems, and external partnerships.
This role will also lead governance frameworks, strategic project management, and Quality support for business development activities including acquisitions, due diligence, and post-close integration. The position partners closely with Quality leadership, R&D functions, Regulatory Affairs, IT, Finance, HR, and external partners to modernize operations and strengthen organizational performance

Key Responsibilities

• Develop and execute a multi-year Operational Excellence roadmap aligned to R&D Quality strategy and enterprise priorities.

• Establish and lead governance processes for the R&D Quality including operating reviews, strategic planning cycles, decision forums, and escalation pathways.

• Drive R&D GXP quality governance models to ensure adequate quality performance and escalation from L2 through L0.

• Support Global Quality efforts, representing R&D quality, on quality governance as needed.

• Drive annual goal setting, portfolio prioritization, budget tracking, and business performance reviews.

• Identify and lead/monitor cross-functional improvement initiatives across audits/inspections, quality systems, CAPA, supplier quality, and oversight models.

• Establish project management standards, tools, and governance for strategic Quality initiatives.

• Lead a portfolio of enterprise and functional projects ensuring scope, timelines, resources, risks, and deliverables are managed.

• Represent R&D Quality in acquisition assessments, licensing opportunities, and strategic partnerships.

• Lead Quality due diligence and execute post-close integration plans for acquired assets.

• In partnership with Global Development, establish KPIs to measure quality performance, efficiency, risk, and project delivery.

• Build operational excellence and project management capability through coaching, training, and mentoring

Enterprise Leadership & Influence

• Act as a trusted advisor to senior leaders, bringing insights and thought leadership on operational performance.

• Demonstrate foresight in identifying emerging challenges and opportunities ("looking around corners").

• Navigate ambiguity with confidence and agility, aligning teams and stakeholders around a common transformation vision

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic leader we seek is an individual with these qualifications

Basic Qualifications:

• Doctorate degree and 5 years of experience in Quality Assurance or Strategy in a regulated industry OR

• Master's degree and 9 years of experience in Quality Assurance or Strategy in a regulated industry OR

• Bachelor's degree and 11 years of experience in Quality Assurance or Strategy in a regulated industry

In addition to meeting at least one of the above requirements, you must have at least 5 years 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:

• Strong knowledge of GxP regulations including GCP, GLP, PV, and quality system management.

• Demonstrated success leading enterprise transformation, governance and complex integration programs.

• Strong executive presence with ability to influence senior stakeholders.

• Advanced degree (MBA, MS in Operations/Engineering, or similar).

• Certification in Lean Six Sigma (Black Belt or Master Black Belt).

• Demonstrated expertise in designing and implementing KPIs and performance management frameworks.

• Strong financial and business acumen; capable of building business cases and measuring ROI.

• High EQ, exceptional communication skills, and experience consulting with senior stakeholders.

• Strategic mindset with operational execution capabilities-able to align vision with delivery.

• Experience integrating data science, AI, or digital tools in operational settings.

• Comfortable with ambiguity and rapid change; thrives in a matrixed, global organization.

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

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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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Salary Range

199,782.30USD -270,293.70USD