Senior Manager- IT Quality

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.

What you will do

Let’s change the world. In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved techniques and procedures. In this position you will monitor activities through internal review and risk assessments of GxP systems per Amgen’s policies and procedures. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN).  The candidate will be required to go into the office as dictated by the site policy. 

As Senior Manager Quality Assurance in the IT Quality organization, you’re in a leadership position with responsibilities to supervise and mentor staff. Each staff member will participate/support different phases of the Information Systems Lifecycle.  As a leader you will focus your efforts on the following workflows in a GxP environment:

Focus Areas

• Computer System Validation (CSV) with a strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards.
• Strong understanding of periodic reviews and audit trail assessments for computer system validations, ensuring compliance, system integrity, and risk identification.
• Manages supplier relationships for software applications, including vendor selection and qualification, contract management, and ensuring timely and quality software delivery.
• Oversees the Quality Management System (QMS) for computerized systems, ensuring compliance, documentation, and continuous process improvement.

Responsibilities

• Strong project management skills with experience supervising quality professionals working with cross functional and global stakeholders across multiple time zones.
• Develop, Mentor, and oversee staff and day-to-day GxP activities.
• Assess and guide the team in performing Periodic Review of Systems and Audit Trail Reviews.
• Manage change controls, validation and review and approval of validation deliverables per procedure (e.g. Validation Plan, Test Strategy, Validation Summary Report, etc.).
• Supplier Management activities for Computerized Systems and other validation disciplines/processes (e.g. Equipment, Analytical, etc.)
• Support, review and approval of failure investigations & CAPA as a Quality Contact pertaining to Computer Systems.
• Business Owner activities for systems owned by Quality Assurance (e.g. SAP QM, Veeva, Kneat).
• Participation and support of regulatory inspections as needed.
• Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems.

The following are some examples of tasks for the position

• Strong understanding of Risks Assessment and how to apply risk-based decision making to all processes related to IT systems.
• Determine and establish requirements for system/equipment or processes.
• Act as a reviewer and approver for SOPs, validation deliverables and /or QMS related records (Deviation/CAPA).
• Review and Approve System Life Cycle Documents (i.e. Validation deliverables).
• Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
• Leverages qualitative insights and quantitative research, analyzes trending data, and utilizes forecasting models and advanced analytical tools to drive continuous improvement in IT quality and performance.
• Anticipates and prevents potential problems.
• Independently develop solutions that are thorough, practical and consistent with functional objectives.
• Provides management review updates on quality metrics, analyzing data and recommending improvements to enhance quality standards.
• Bring topics and critical decisions to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes compliance.

Basic Qualification

• Master’s degree with a minimum of 10 years experience in Software and Systems Quality assurance (Experience of minimum 5 years in leading teams in this area of expertise and foster an environment of strong collaboration) OR
• Bachelor’s degree with a minimum of 14 years experience in Software and Systems Quality assurance (Experience of minimum 5 years in leading teams in this area of expertise and foster an environment of strong collaboration).
• Strong understanding and ability to apply GxP requirements in Information systems.
• Possesses a strong understanding of industry standards and business principles.
• Contributes to work group/team by ensuring quality of tasks/ services provided by self and others.
• Candidate may need to work hours outside the standard workday or work in different time zones to support business needs.

Preferred skills

• Demonstrated experience (3-5 years) training others in activities outline above.
• Establish/Improve and actively participate in training curriculum and delivery of this material.

What we expect from you

We are all different, yet we all use our unique contributions to serve patients.

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 with 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