• Job Description

  Req#: R-176291

  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.

  Sr. Director, GxP Learning and Performance Process Owner

  Live

  What you will do

  Let’s do this! Let’s change the world! In this vital role you will lead the development and implementation of modernized, risk-based learning and training end to end processes supporting the regulated areas across the product lifecycle. This role will implement a Global, Enterprise-wide strategy for the Amgen GxP Quality Management Operating Model and ensure alignment across R&D and Operations. The incumbent will collaborate across R&D, Operations and Commercial in defining and integrating the elements of the Quality Operating Model inclusive of Process Excellence, Digital, People/Culture and Operational Excellence that supports Learning and Performance. As part of this the incumbent will also be responsible for developing Learning and Training GxP strategy required to integrate other companies associated with mergers and acquisitions. The role will need to ensure understanding of the R&D, Operations, and Commercial strategy in order to enhance the competitive advantage of the GxP Quality Management Operating System (QMOS) and drive performance improvements in alignment with business needs and priorities. To achieve this objective, the position partners closely with Senior Leadership across R&D and Operations (Discovery Research, Translational Sciences, Global Regulatory Affairs and Safety, Global Development, Global Medical Affairs, and Manufacturing, Supply Chain, Product Development, Central Strategy Functions, Compliance, and Audit). The position also collaborates with learning and performance leaders external to Amgen in benchmarking and continuous improvement.

  Primary Responsibilities

  • As the GxP Process Owner, define, implement and continuously improve the end-to-end GxP learning and performance processes that are part of the GxP QMS Process Architecture.
  • Manage a team of GMP Learning & Performance professionals
  • Define and manage speed to contribution across GxP. This includes defining and optimizing new competency-based processes that can replace or supplement read and understand approaches to training.
  • Own, implement, and continuously improve all associated GxP documents (policies, standards, procedures, work instructions) that define the requirements for training, curriculum management, job descriptions/CVs and qualification in support of staff performing regulated activities.
  • Ensure that QMS learning-related documents are in a continued state of compliance to global regulatory requirements and expectations.
  • Serves as the point of contact and collaborate with SMEs across the organization for all audits and external HA inspections, including providing inspection readiness and training to local group/site staff in this area.
  • Lead and defines the Integration Strategy for Learning and Performance for merges and acquisitions including the connection and consolidation of LMSs across companies and the digital aspects and requirements from DTI and DTI QA oversight areas.
  • Integrate Leaning and Performance requirements across the GxP functions across the network.
  • Serve as a Single Point of Contact to support the Learning strategies in support of the broader GxP Process architecture across the different GxP functions including and advisor role in the generation of training strategies across the network.

  Win

  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 collaborative leader with these qualifications.

  Basic Qualifications:

  • Doctorate Degree and 5 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector or equivalent

  Or

  • Master’s Degree and 8 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector or equivalent

  Or

  • Bachelor’s Degree and 10 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector or equivalent

  And

  • 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

  Preferred Qualifications:

  • Prior experience in the Learning and Training area across R&D and/or Operations coupled with deep quality experience on the regulatory expectations of learning and training across GxP.
  • Experience managing Quality Management in a GxP domain or across all domains including driving change across functions.
  • Strong knowledge of adult learning theory and previous experience in learning and performance supporting pharma preferred
  • Demonstrated track record leading high-performing teams within the biotechnology and/or pharmaceutical industry
  • Ability to create, grow, and develop high performing teams that deliver outstanding business results
  • Experience fostering an environment that drives creativity and innovation
  • Ability to operate independently in a strategic and tactical manner and ability to work through ambiguity across GxP in designing and implementing learning and training solutions
  • Ability to partner effectively with stakeholders at senior and junior levels and develop broad-based solution designed to meet a variety of organizational and business needs
  • Exceptional oral and written communication and writing skills

  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.

  The annual base salary range for this opportunity in the U.S. is $180,000 - $240,000.

  In addition to the base salary, 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.

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  Salary Range

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• About the company

  Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

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