Are you passionate about quality assurance in IT systems and eager to make a difference in the biotechnology industry? Amgen, a global biotech leader, is hiring a Senior Specialist – IT Quality in Hyderabad, India. This role offers a unique opportunity to lead the validation of GxP computerized systems, ensure regulatory compliance, and contribute to Amgen’s mission of serving patients with serious illnesses. If you’re skilled in Computer Software Assurance (CSA), risk-based validation, and cross-functional collaboration, join Amgen to transform lives through innovative medicines.
Responsibilities
As a Senior Specialist in IT Quality at Amgen, you will play a pivotal role in ensuring the quality and compliance of GxP systems. Your key responsibilities include:
- Conducting risk assessments for GxP computerized systems to ensure compliance with global regulatory requirements.
- Leading the full lifecycle of GxP system validation, including risk assessment, business requirements, configuration specifications, traceability matrix, and IQ/OQ/PQ protocols.
- Overseeing qualification and revalidation efforts for systems like SAP ERP (including S4/HANA), LIMS, ELN, CDS, QMS, MES, and cloud-hosted platforms.
- Reviewing and approving validation deliverables, such as Validation Plans, Test Strategies, and Validation Summary Reports.
- Managing change control processes to maintain validation integrity and ensure audit trail compliance.
- Partnering with cross-functional teams to drive AI readiness and integrate emerging technologies into compliance systems while ensuring data integrity.
- Conducting periodic reviews and audit trail assessments to maintain system integrity and identify risks.
- Managing supplier relationships for software applications, including vendor selection, qualification, and contract management.
- Supporting regulatory inspections and reducing audit findings through effective inspection readiness.
- Collaborating with global stakeholders to align on quality outcomes and industry benchmarks.
Qualifications
To excel in this role, candidates must meet the following requirements:
- Master’s degree with at least 10 years of experience in Software and Systems Quality Assurance, including 5 years in a leadership role fostering collaboration, OR a Bachelor’s degree with 14 years of relevant experience, including 5 years in leadership.
- Profound knowledge of global regulations governing GxP computerized systems and emerging technologies like AI.
- Expertise in Computer Software Assurance (CSA), risk-based validation, and tools like ServiceNow, Jira, Confluence, HP ALM, Veeva Vault, and TrackWise.
- Strong understanding of GxP, SOX, and other regulatory requirements for validation, change management, and deviation management.
- Proven project management skills, with experience managing cross-functional and global teams across multiple time zones.
- Excellent communication, negotiation, and interpersonal skills to influence strategic direction and drive implementation.
- Familiarity with ITIL, Agile methodologies, DevOps, CI/CD, and cloud-native architectures.
- Ability to work outside standard hours or in different time zones to support business needs.
- Preferred: 3-5 years of experience training teams in quality assurance processes and building dashboards using tools like Power BI, Tableau, or Spotfire.
Benefits
Amgen is committed to supporting your professional and personal growth. As a Senior Specialist, you’ll enjoy:
- Competitive salary aligned with industry standards (estimated range: INR 20,00,000–30,00,000 annually).
- Comprehensive Total Rewards Plan, including health benefits, retirement plans, and wellness programs.
- A collaborative and innovative culture that fosters scientific advancement and teamwork.
- Opportunities to work on cutting-edge technologies like AI and cloud-hosted GxP platforms.
- Career development through training, mentorship, and global exposure.
- An inclusive workplace that values diversity and provides reasonable accommodations for individuals with disabilities.
How to Apply
Ready to join Amgen’s mission to serve patients? Apply now through the official Amgen careers portal at careers.amgen.com. Submit your resume and cover letter, highlighting your experience in IT quality assurance and GxP system validation. For accommodation requests, contact Amgen’s HR team via the careers portal. Applications are accepted until October 23, 2025.
FAQs
Q: What is the work schedule for the Senior Specialist – IT Quality role?
A: This is a full-time, on-site role in Hyderabad, India. Candidates must adhere to Amgen’s site policy for office attendance and may need to work outside standard hours to support global teams.
Q: What systems will I work with in this role?
A: You’ll work with GxP systems like SAP ERP (S4/HANA), LIMS, ELN, CDS, QMS, MES, and cloud-hosted platforms, using tools like ServiceNow, Jira, and Veeva Vault.
About Amgen
Amgen is a global biotechnology pioneer dedicated to unlocking the potential of biology to treat serious illnesses. Since 1980, Amgen has reached millions of patients through innovative therapies in Oncology, Inflammation, General Medicine, and Rare Disease. With a collaborative, science-driven culture, Amgen fosters an inclusive environment where diverse professionals work together to advance human health. Learn more at www.amgen.com or follow Amgen on Twitter at twitter.com/amgen.
