• Job Description

  Req#: R-177276

  Career Category

  Quality

  Job Description

  HOW MIGHT YOU DEFY IMAGINATION?

  At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

  Executive Director, GxP Quality Digital

  Live

  What you will do

  Let’s do this. Let’s change the world. In this vital role as the Executive Director, you will lead the development and execution of a Global, Enterprise-wide strategy for the Amgen GxP Quality Management Operating Model. This position will be classified as a remote position and will report to the Vice President, Quality Operating Systems, Services and Sciences.

  In this position, the candidate will collaborate across R&D, Operations and Commercial in defining and integrating the elements of the operating model inclusive of Process Excellence, Digital, People/Culture and Operational Excellence. As part of this the incumbent will also be responsible for developing GxP strategy required to integrate other companies associated with mergers and acquisitions.

  The role will need to ensure deep understanding of the R&D, Operations and Commercial strategy in order to maximize the competitive advantage of the GxP Quality Management Operating System (QMOS) to 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 Global QMS leaders external to Amgen in benchmarking and continuous improvement.

  Responsibilities

  • Manage a staff of Sr. Director/Directors and professional staff in the range of 10 to 30 individuals.

  • Design and integrate the Quality Management Systems into a modern GxP Quality Management Operating System across each of the four elements as defined above.

  • Define process excellence and an integrated process architecture to account for all of the end-to-end processes required to facilitate a drug or biologic across development, through registration and into full commercialization.

  • A second key aspect of process excellence will require assessing the document management maturity and defining a new vision for a GxP document landscape ensuring it is effective and simplified.

  • For the Digital element of the QMS, this role will have direct oversight for the Global Quality Digital group that supports development and execution of the GQ Digital strategy.

  • For the People/Culture element of QMOS, redefine the role of the process owner considering the new capabilities required to drive improvement in processes across GxP vs those processes whose scope is in within one domain of GxP (e.g., GMP).

  • Work with HR and business functions, to assess and appoint process owners according to the evolved maturity required to drive transformation change.

  • Manage a GxP Document Management Process Owner that will own the document hierarchy across GxP including all associated templates.

  • For the Operational Excellence element of QMOS, define and implement process health metrics designed to monitor the overall health and risk of the QMOS including all associated ROI related to the Quality process and digital architecture.

  • Oversees the day-to-day digital operational activities in GQ to ensure all projects are being progressed in line with budget and ROI expectations. Escalates issues as appropriate. Also plays a critical role in defining the AI strategy in the GxP space aligned with the broader enterprise strategy on AI.

  • Develop and facilitate the Level 0 Management Review Process across R&D, Operations and Commercial. Appoint a GxP Management Review process owner whose sole role will be to manage this process including collaborating across functions in the design and implementation. This role will also own the future development of the Quality Management Maturity Model as regulatory guidance evolves in this area.

  • Serve as the integration lead for designing and executing M&A strategy relative to the QMOM. Design and implement process risk assessments required to determine areas of opportunity relative to process improvement across GxP. Represent Quality on cross-functional integration office forums.

  • Play a lead role in presenting the Amgen QMOS external health authorities during regulatory inspections and audits. Ensures that effective processes are in place to keep the QMS in a state of compliance with external, global regulatory requirements across GxP.

  • Participates in Industry forums designed to benchmark and continuously improve in the areas of Quality Management.

  Win

  What we expect of you

  We are all different, yet we all use our unique contributions to serve patients. The Executive Director we seek is an experienced leader with the following qualifications. They will also embody the Amgen leadership attributes which are:

  • Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive

  • Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection

  • Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders

  • Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

  Basic Qualifications:

  • Doctorate degree & 6 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector or equivalent OR

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

  • Bachelor’s degree & 12 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector or equivalent AND

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

  Preferred Qualifications:

  • Prior experience in the Digital space across R&D and/or Operations coupled with technical expertise supporting a GxP area or Product Development.

  • Experience managing Quality Management in a GxP domain or across all domains including driving change across functions.

  • Demonstrated track record leading high-performing teams within the biotechnology and/or pharmaceutical industry

  • Understanding of the legal and regulatory environment affecting PhRMA/Biotech

  • 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 $250,054-$313,603.

  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

  Amgen’s Commitment to Our Staff

  At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our “people-first” philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.

  We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

  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.

  .

  Salary Range

  252,723.00 USD - 301,470.00 USD

• 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.

Notice