Quality Associate Director

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Quality Associate Director

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for the development and execution of core technology-based competencies focusing on Artificial Intelligence to enable the Quality strategy aligned with our long-term aspiration and follows the expectations of international regulatory agencies.

• 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.

What we expect of you

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 Qualifications:

• 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 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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

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

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As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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.