Quality Associate Director

Key Responsibilities

• Support the Quality vision and mission for the Center aligned with Amgen’s mission to serve patients.
• Support Amgen Site Quality Head in the development and implementation of a multi-year Quality technology roadmap aligned with Amgen’s 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 Amgen’s 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.

Qualification & Requirements

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic

• Doctorate degree and 3 years of leading teams focused on the application of emerging technologies to Quality systems OR
• Master’s degree and 10 to 14 years of leading teams focused on the application of emerging technologies to Quality systems OR
• Bachelor’s 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

• 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

Benefits

Health

• Medical, Dental & Vision
• Wellness programs, tools and resources to incentivize healthy living
• Global Employee Assistance Program
• Cancer support resources through Wellness at Amgen
• Variety of saving options for eligible medical expenses
• On-site fitness facility (in some locations), Reimbursed or discounted access to local fitness facilities (in some locations)
• Assistance for special needs children
• 100% for Amgen products when enrolled in an Anthem medical plan

Finance

• Competitive base pay and annual bonus opportunities
• Long-term incentives and stock grants
• Award-winning retirement plans and 401(k) with generous company match
• Retiree medical savings accounts
• Short- and long-term disability benefits and life insurance
• Amgen Inc. Employee Stock Purchase Plan (U.S. only)
• Dependent care savings options

Work/Life Balance

• Award-winning Paid Time Off (PTO) program plan
• Bi-annual company shutdowns (U.S. only)
• Adoption support
• Employee volunteer program and company matching donation program
• On-site child care facilities (in some locations) and/or discount options (in some locations)
• Access to tutoring, test prep, and college admissions advice services for children
• Elder care resources

Career

• Tuition reimbursement
• Flexible work environment
• Employee recognition programs
• Learning and development resources
• Service awards
• Mentor program
• Access to more than 20 employee resource groups