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Sr Associate Quality Compliance

3-5 years
Not Disclosed
10 Sept. 9, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description – Sr Associate Quality Compliance (Process Modeler)

Company:

Amgen

Location:

  • India – Hyderabad

Work Location Type:

On-Site

Job ID:

R-223936

Date Posted:

September 03, 2025

Category:

Quality

Role GCF:

4


About Amgen

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, making people’s lives easier, fuller, and longer. For over 40 years, Amgen has led the biotechnology industry, discovering, developing, manufacturing, and delivering innovative medicines to millions of patients worldwide. Today, we continue to push the boundaries of innovation through advanced technology and human genetic data.


About the Role

As a Sr Associate Quality Compliance – Process Modeler, you will play a key role in creating business process models within the Amgen process modeling framework. You will collaborate with subject matter experts (SMEs) and stakeholders globally to translate discussions into process flows, procedures, and controlled documents.

This role requires strong analytical, communication, and facilitation skills, along with proficiency in Microsoft Visio and related tools.


Key Responsibilities

  • Translate SME and stakeholder discussions into process flows and documentation.

  • Lead workshops, interviews, and other information-gathering activities to derive process structures and measures.

  • Develop and maintain process models using Amgen’s methodology and Visio templates (training provided).

  • Gain proficiency in process management systems, templates, and metamodels (training provided).

  • Act as a subject matter expert in modeling, supporting cross-functional stakeholders.

  • Escalate and resolve process issues where needed.

  • Collaborate with SMEs globally to ensure stakeholder input in developing/revising process models.

  • Provide regular updates to business customers, reporting on progress, challenges, and deliverables.

  • Work closely with documentation, training, and project teams to support project implementation.


Qualifications & Experience

  • Education: Master’s degree in Sciences or related field.

  • Experience: 3–5 years in Pharmaceutical, Biotechnology, or Clinical Research industry.


Functional Skills

Must-Have Skills:

  • Strong ability to translate discussions into process flows and documentation.

  • Knowledge of developing SOPs and controlled documents from process models.

  • Facilitation skills to drive teams toward shared goals.

  • Advanced proficiency in Microsoft Visio.

  • Intermediate proficiency in Microsoft Project, Word, SharePoint Online, Teams, and Smartsheet.

Good-to-Have Skills:

  • Prior experience as a Business Analyst is a plus.


Soft Skills

  • Exceptional communication (written & verbal) and active listening skills.

  • Strong analytical, abstraction, and problem-solving abilities.

  • Ability to prioritize and execute tasks under pressure.

  • Effective collaboration at all organizational levels.

  • Self-starter, independent, resourceful, and capable of making sound judgments.

  • Team-oriented mindset with the ability to work through others.