Quality Associate Director

Job Description

- 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

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