R&D Clinical - Quality Compliance Senior Manager

Amgen; Hyderabad; On-site; INR 4,000,000 - 7,000,000; Full time

Benefits offered by this job

Flexible work arrangements

Total rewards package

Job summary

Amgen Inc. in Hyderabad, India is seeking an experienced R&D Clinical Quality Compliance Senior Manager to lead QA for global clinical trials. You will drive quality by design and RBQM across protocol development through regulatory submission, ensuring inspection readiness and continuous improvement.

The role requires strong GCP knowledge, extensive QA leadership, and ability to mentor junior staff while leveraging AI tools to streamline processes and decision-making.

Qualifications

• Master's degree in Life Sciences or related field required.
• 15–18 years in biotech/pharma/CRO with QA oversight.
• Deep knowledge of ICH GCP and regulatory readiness.

Responsibilities

• Advise study teams throughout clinical trial life cycle on GCP and QA.
• Review study protocols and amendments for quality by design.
• Lead risk-based quality management activities and RBQM.
• Guide QA input into critical study documents and plans.
• Direct teams to resolve complex quality issues.
• Support inspection readiness and regulatory submissions.
• Perform quality data metrics analysis to drive improvements.
• Mentor junior staff and provide line management as applicable.
• Leverage AI tools to streamline workflows and enhance decisions.

Skills

GCP knowledge

Quality Assurance

RBQM experience

AI in QA

Line management

Stakeholder communication

Study protocol review

Education

Master's Degree in Life Sciences

Tools

Veeva Vault

eTMF

Job description

Career Category Quality Job 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.

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

• 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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen