Quality Compliance Manager

Posted:
12/19/2024, 8:04:32 PM

Location(s):
Hyderabad, Telangana, India ⋅ Telangana, India

Experience Level(s):
Mid Level ⋅ Senior

Field(s):
Legal & Compliance

Career Category

Quality

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 Compliance Manager

What you will do

Let’s do this. Let’s change the world. In this vital role you will be part of Project management of Amgen’s Good Clinical, Laboratory, and Manufacturing Practices (GxP) Intelligence with focus on operations and GMP/GDP/CMC/QMS

  • Gain knowledge internally and externally regarding early signals, current hot topics, and evolving issues impacting Amgen Operations globally and in designated region/countries.

  • Set up, handle, and improve related data bases/Quality Systems

  • Conduct assessments, analysis of data sources, and communication back into the organization through established channels.

  • Work internally to gain alignment, support, and scientific knowledge on related developments in external landscape.

  • Undertaking additional projects with focus on accountabilities or development opportunities, as applicable.

  • Provide support and act as backup to one another position in Quality

  • Networking across various internal functions including GRAAS-CMC and R&D Policy; liaison with VA&P / Governmental Affairs, quality & supply chain, manufacturing / development sites and affiliates, as appropriate

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek should have these qualifications.

Basic Qualifications:

  • Doctorate degree and 1 year of relevant experience OR,

  • Master’s degree and 6 to 8 years of relevant experience OR,

  • Bachelor’s degree and 8 to 10 years of relevant experience OR

  • Diploma and 12 to 14 years of relevant experience

  • Excellent communication skills

  • Strong project management background

  • Conflict resolution

  • Team- and Network building

  • Good organization, planning and prioritization capability

  • Time management

  • Attention to details

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.

careers.amgen.com

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.

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