Senior Director, Gxp Quality

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Senior Director, GxP Quality

What you will do

Lets do this! Lets change the world! In this vital role as the Senior 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 enhance 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.

• Lead a team of professional staff in the range of 5 to 15 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 partner with 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 be responsible for 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 return on investment related to the Quality process and digital architecture.
• Manage a GxP Management Review process owner whose role will be to handle this process including collaborating across functions in the design and implementation. This role will also lead 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Senior 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

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

OR

• Masters degree & 9 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector or equivalent

OR

• Bachelors degree & 11 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector or equivalent

AND

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.

• Prior experience in the Digital space across R&D and/or Operations coupled with technical expertise supporting a GxP area or Product Development.
• Experience leading Quality Management in a GxP domain or across all domains including inspiring 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 team members at senior and junior levels and develop broad-based solution designed to meet a variety of organizational and business needs
• Outstanding oral and written communication and writing skills

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 expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $206,769 - $235,413. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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.