QA Associate Director

What you will do

Lets do this. Lets change the world. In this vital role, you will be responsible for development and implementation of a GxP Gen AI risk framework aligned to global regulations. This framework will be aligned under the umbrella of the broader Enterprise risk governance process led by DTI. This process will support using Gen AI solutions to support GxP activities and decisions and will be an End to End process as part of Amgen Quality Management System.

• Streamlining and regulating the GxP Artificial Intelligence Governance Process and developing the strategic Artificial Intelligence roadmap, including lifecycle management and all associated standards, policies and procedures associated with this process.
• Applicability and implementation of Artificial Intelligence solutions across different GxP areas throughout the enterprise. These solutions will use traditional AI technology (Analytical AI, Natural Language Processing) and Generative AI.
• Providing oversight to the implementation of process Improvement plans and implementing operational excellence strategies and roadmaps in alignment with the E2E Quality Strategy.
• Establishing, monitoring, and reporting key performance indicators and scorecards to continuously assess and sustain the health of the Artificial Intelligence Governance program across the network.
• Accountable for the leadership of the Global Artificial Intelligence Network, ensuring standardization across the network while driving simplification efforts in a Continuous Improvement approach and ownership of the documentation ecosystem, including oversight of gap assessments to new regulatory requirements, regulatory commitments, and responses to audit & inspection findings.
• Performing external benchmarking across the industry to ensure Amgen is aligned with standards defining the application and use of GenAI tools and ensuring the appropriate level of governance oversight is applied to these use cases.
• Designing and implementing Artificial Intelligence programs for staff at all organizational levels while ensuring collaboration with cross-functional teams to identify problems, inefficiencies, and streamline opportunities, focusing on operational excellence principles, tools, and techniques that enable a culture of continuous improvement.
• Implementing new technologies and methodologies that can further enhance operational efficiencies while implementing industry best practices.
• Instrumental in defining training content that supports developing competency in this area as a new capability and our inspection readiness relative to the process.
• This position will be classified as a remote position with travel required and will report to the QA Director of Quality Management Systems.
• Collaborate across R&D, Operations, and Commercial in defining and integrating the elements of the Artificial Intelligence, Digital, People/Culture, and Operational Excellence that support the GxP Amgens Quality Management System.
• Collaborate with QMS leaders external to Amgen in benchmarking, sharing best practices, and continuous improvement initiatives.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The GPO (Global Process Owner) professional we seek should possess these qualifications.

Basic Qualifications:

• Masters degree & 10 to 14 years of R&D, Operations, and/or Quality experience in the PhRMA/Biotech sector or equivalent OR
• Bachelors degree & 14 to 16 years of R&D, Operations, and/or Quality experience in the Pharma/Biotech sector or equivalent
• 3 plus years of direct managerial experience handling people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Preferred Qualifications:

• Prior experience in the QMS, Artificial Intelligence across R&D and/or Operations, coupled with deep quality experience on the regulatory expectations across GxP.
• Ability to create, grow, and develop strong 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 QMS Continuous Improvement Initiatives.
• Ability to partner effectively with key collaborators at senior and junior levels and develop broad-based solutions designed to meet a variety of organizational and business needs
• Exceptional oral and written communication and writing skills