Quality Associate Director

• Support the Quality vision and mission for the Center aligned with Amgens mission to serve patients.
• Support Amgen Site Quality Head in the development and implementation of a multi-year Quality technology roadmap aligned with Amgens standards and overall strategic imperatives.
• Ensure applicable activities align with GxP regulatory requirements, promoting execution excellence and a strong Quality culture.
• Collaborate with local and global partners to ensure Amgen India future regulatory inspection readiness.
• Deliver Quality service level agreements with other Amgen sites and key collaborators.
• Partner with cross-functional digital and technology teams and serve as a Quality point of contact to develop and establish core Amgen India technological capabilities focusing on Artificial Intelligence.
• Leverage emerging technologies, such as artificial intelligence, to enhance Quality systems, regulatory compliance and drive operational efficiencies
• Attract and recruit top talent aligned with the overall Quality organization hiring plan.
• Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of Amgens Leadership Attributes.
• Responsible for managing, growing, and developing a core digital technologies team in India, ensuring global ways of working are imbedded in the local organization.
• Develop and deliver team goals aligned with Amgen Quality & Corporate goals.
• Oversee unit expenditures and manage budget to ensure adherence to financial targets.

Basic Qualifications:

• Doctorate degree and 3 years of leading teams focused on the application of emerging technologies to Quality systems OR
• Masters degree and 10 to 14 years of leading teams focused on the application of emerging technologies to Quality systems OR
• Bachelors degree and 14 to 16 years of leading teams focused on the application of emerging technologies to Quality systems OR
• Diploma and 18 to 20 years of leading teams focused on the application of emerging technologies to Quality systems

Preferred Qualifications:

• A consistent record of prior experience leading teams focused on the application of emerging technologies to Quality systems.
• 10+ experience in leadership roles in the pharmaceutical industry.
• PhD, MS or BS in life sciences or Engineering degree preferably in Computer Science/Artificial Intelligence.
• Demonstrated ability to drive and contribute to large digital transformation programs and collaborate seamlessly with cross-functional matrixed teams
• Demonstrated expertise in the application of digital technologies (including AI) to Quality operations.
• Experience in digital application lifecycle management, and Agile development methodologies.
• Experience in people management and passion for mentorship, culture and fostering the development of talent.
• Strong experience in Quality Management Systems oversight and implementation.
• Ability to lead change management and transformation of a Quality function.
• In depth knowledge on the application of emerging technologies to global GxP regulations impacting quality activities in the pharmaceutical industry.
• Excellent verbal and written communication skills/writing skills; active listening skills; attention to detail. Strong process/business writing skills.
• Ability to translate business and key collaborator feedback into accurate and efficient processes using unambiguous language and format.
• Strong analytical/critical-thinking and decision-making abilities.
• Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
• Fluency in English (written and spoken).
• Ability to 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 get 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