Director, GxP Learning & Performance - Process, Governance, and Metrics

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, GxP Learning & Performance - Process, Governance, and Metrics

What you will do

Let’s do this. Let’s change the world. In this vital role you will drive the Learning process optimization and improvement across Global Quality and GxP in partnership with critical stakeholders across the matrix. This will include serving as the key point of contact for GxP Learning Community of Practice (CoP) and the Training Management Processes across the Learning Ecosystem (Operations and R&D). The position will drive achievement of GxP outcomes through continuous improvement, metrics, and overall growth and transformation of the learning landscape through local SMEs and local learning leads.

• Driving change management to promote a culture of continuous improvement and embedding it into our daily work, partnering with cross functional leadership in developing and rolling out a culture of learning performance.
• Building, maintaining, and leveraging relationships across the pillars to find opportunities for process improvement, facilitate the implementation of process improvement, and continuously monitor processes and outcomes.
• Maintain global processes, procedures, and training materials in compliance with Global GxP requirements, Amgen Global Quality Standards, and Amgen’s Quality Management System (QMS) principles.
• Define Community of Practice (CoP), including roles, operating mechanisms, communication strategies, and governance of learning processes to drive continuous improvement.
• Develop and implement a risk-based learning approach for E2E processes supporting regulated functional areas across the product lifecycle.
• Provide leadership, coaching, and training for CoP including both technical processes and behaviors necessary to optimize process execution.
• Assess, analyze, and implement solutions across the Learning Ecosystem to identify and eliminate waste.
• Key partner in building capabilities and driving quality growth mindset to establish a center of excellence for Quality capability building, defining standards, deployment model, in collaboration with Quality Leadership and key learning leads.
• Optimize competency / capability-based processes to replace and/or supplement read & understood methodology
• Participate / Lead regulatory surveillance and benchmarking initiatives with peers externally to stay abreast of changes in regulations that affect impacted processes and to identify new ways of working and evolving technology in the learning space.
• Define process monitoring methods, including data collection and analysis, metrics, and associated targets, and reporting mechanisms, including both quality, operations, and R&D processes
• Support site and functions during regulatory inspections and audits, which may include direct work with inspectors/auditors and writing / reviewing responses.
• Through major initiatives (e.g. integration, divestiture, or reorganization) serve and/or lead program teams, manage interim state of operations, ensure establishment of defined future state or processes, as applicable.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of Operations and/or Development experience

Or

Master’s degree and 8 years of Operations and/or Development experience

Or

Bachelor’s degree and 10 years of Operations and/or Development experience

In addition to meeting at least one of the above requirements, you must have at least 4 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:

• 12 years’ experience in Operations, Development and / or related functions, experience in biopharmaceutical / life sciences industries preferred.
• Bachelor’s degree in Business Administration, Operations Management, Engineering, or related fields.
• Master’s degree in Organizational Development, Leadership and Development, or related fields.
• Strategic agility—strong and demonstrated critical thinking capability with shown success and discipline to focus on execution of strategic decisions while balancing conflicting priorities
• Process Effectiveness and Drive for Results—ability to provide innovative ideas to optimize the function and generate new ideas or alternatives that bring value including seeking new information and external insights.
• Exceptional capability to build alignment with senior level business partners
• Demonstrated strong ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives
• Demonstrated leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.
• Competency in developing strategic plans, as well as directing tactical execution
• Successful track record of building, leading, and maintain a successful and highly motivated team

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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