R&D Clinical - Quality Compliance Senior Manager
Amgen · Hyderabad
Career Category
QualityJob Description
HOW MIGHT YOU DEFY IMAGINATION?
At Amgen, every challenge is an opportunity. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Join us.
LIVE
WHAT YOU WILL DO
We are hiring a R&D Clinical Quality Compliance Senior Manager, who will operate in the Therapeutic Area Quality Department.
In this critical position, you will deliver comprehensive, proactive quality support throughout the relevant Therapeutic area clinical development program, contributing to the design and execution of a risk-based quality assurance strategy. This approach integrates quality by design principles and Risk Based Quality Management (RBQM) principles at every stage, from protocol development through database lock to regulatory submission and approval.
You will oversee quality management and verify compliance for global clinical trials by supporting study teams involved in Amgen-sponsored Trials.
RESPONSIBILITIES
Key advisor to the study team throughout the clinical trial life cycle, providing independent and objective quality input in the areas of GCP and compliance with Amgen SOPs and processes.
Review and provide input into the development of the initial clinical study protocol and subsequent amendments, with focus on quality by design, confirming it’s fit for purpose, clear, concise and consistent.
Actively provide input into study risk assessment activities.
Review and provide input into other key study documents and plans.
Direct study teams through the management of complex quality issues
Participate in key activities related to Risk Based Quality Management.
Using available tools, analyze quality data metrics
Monthly meetings with study team lead/associate director, to review the following: on-going quality issues, quality trends, program filing timelines, inspection readiness, potential inspections and audit scheduling and planning and any other topics deemed relevant.
Support the clinical study team with inspection readiness activities.
Support continuous improvement initiatives within TA Quality
Liaise with other functions within the Quality Organization
Mentor or coach to junior colleagues.
Line management responsibilities, as applicable.
Demonstrated ability to use artificial intelligence (AI) tools and technologies to streamline workflows, drive process automation, and support data-driven decision-making.
Must be adept at identifying opportunities to apply AI for operational efficiency and continuous improvement initiatives.
WIN
WHAT WE EXPECT OF YOU
We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and:
Master’s Degree in appropriate discipline e.g. Life Sciences, Medical.
15-18 years’ experience working in Biotech, Pharmaceutical or CRO company.
In-depth knowledge of ICH GCP.
Extensive experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are core responsibilities.
Experience using electronic QMS such as Veeva Vault and eTMF.
Experience and understanding of Clinical R&D activities and Global Regulations.
In-depth knowledge of the Regulatory Submission and Inspection readiness, preparation and management procedures.
Extensive experience in Quality Oversight of Clinical Trials, including clinical trial protocol development and execution.
Strong verbal and written communication skills, including strong business writing abilities and active listening.
Strong analytical, critical-thinking, and decision-making abilities.
Capability to understand and articulate technical concepts and literature in spoken and written English.
Up to date knowledge of regulatory intelligence and industry trends.
Reasonable business travel may be required
THRIVE
WHAT YOU CAN EXPECT OF US
Varied opportunities to learn, develop, and move up and across our global organization.
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.
Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.
Flexible work arrangements.
FOR A CAREER THAT DEFIES IMAGINATION
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
CAREERS.AMGEN.COM
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will verify 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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