Sr Associate Quality Compliance

7 hours ago

Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 36,00,000 per year

R&D Quality Senior Associate

What you will do

In this vital role the R&D Quality Senior Associate will play a crucial part in ensuring our organization's compliance with regulatory standards and preparing and coordinating a cross-functional team for Regulatory Health Authority inspections globally. The role also involves supporting the development of inspection management plans for each identified Regulatory Health Authority inspection, managing the R&D inspection framework, and ensuring appropriate inspection resourcing and alignment across time zones. Additionally, the individual will support Regulatory Inspection Intelligence processes and contribute to operational quality initiatives.

Responsibilities:

  • Manage the R&D inspection Framework (Calendars, Distribution Lists, Inspection notifications, SharePoint Sites, MSTeams Sites/Channels, Training Content, etc).
  • Ensures that a cross-functional team (e.g. Quality, Clinical Operations, other functional areas, PV/GPS, GRAAS, DTI, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
  • Supports the development of inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.

  • Organizes mock interviews and/or inspections in preparation of potential Sponsor inspections.

  • Liaise with R&D Quality TA Leads to develop appropriate inspection resourcing/scaling and facilities across time-zones and align TA compliance risk identified contact (CT-RACT, specific risk management items e.g. imaging approaches).

  • Support Regulatory Inspection Intelligence processes and provide input into Operational Quality Initiatives.

Be part of our team

The Clinical Quality Inspection team is a diverse international team within the Global R&D Quality organisation. We are in charge of strengthening and enhancing the R&D Quality Inspection Management System, providing Quality oversight on R&D processes, and leading activities related to GCP regulatory inspections.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

  • Degree Educated
  • 3-6 years of Experience in inspection management within the pharmaceutical or biotechnology industry preferred.
  • Knowledge of global regulatory requirements and inspection processes.
  • Excellent communication and presentation skills.
  • Proven ability to work effectively in a cross-functional team environment.
  • Strong organizational and project management skills.
  • Experience with SharePoint and other inspection management tools.
  • Strong problem-solving skills and the ability to escalate issues effectively.
  • Ability to travel domestically and/or internationally, depending on business needs, to attend inspections as needed.

  • Sr Associate Quality Compliance

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Career CategoryQualityJob DescriptionSr Associate Quality ComplianceRole Name: Sr Associate Quality Compliance – Process ModelerDepartment Name: R&D QualityRole GCF: 4ABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and...

  • Prod Compliance Associate Sr

    2 weeks ago

    Hyderabad, Telangana, India Amazon Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    "Please note that this job is a seasonal role (FTC) for 12 months on the payroll of Amazon."Job Description is looking for a smart, enthusiastic, hard-working, and creative candidate to join the Brand Protection Business Operations team as a Prod Compliance Associate Sr. This position offers an exciting introduction to the Amazon Marketplace and provides a...

  • Sr Associate Quality Compliance

    1 week ago

    Hyderabad, Telangana, India Amgen Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Role Name: Sr Associate Quality Compliance – Documentation LeadDepartment Name: R&D QualityRole GCF: 4ABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen...

  • Sr. Associate Quality Compliance

    12 hours ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Department Name: R&D QualityRole GCF: 4Role Description:The Sr Associate Quality Compliance - Process Modeler gathers and analyses information from a variety of sources (SMEs, documentation, and technical) to create business process models within the Amgen process modeling methodology framework, using specified Visio templates. In addition, the Process...

  • Sr Associate Quality Compliance

    1 week ago

    Hyderabad, Telangana, India Amgen Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    If you feel like you're part of something bigger, it's because you are. 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 read over 10...

  • Associate Quality Compliance

    2 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Role Name: Associate Quality ComplianceDepartment Name: R&D QualityRole GCF: 3ABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the...

  • Associate Quality Compliance

    2 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Career CategoryQualityJob DescriptionRole Name: Associate Quality ComplianceDepartment Name: R&D QualityRole GCF: 3ABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of...

  • Prod Compliance Associate Sr, Selection Validation

    2 weeks ago

    Hyderabad, Telangana, India Amazon Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    ***"Please note that this job is a seasonal role (FTC) for 12 months on the payroll of Amazon" **** is looking for a smart, enthusiastic, hard-working, and creative candidate to join the Selection Validation team as a Product Compliance Associate Sr. This position offers an exciting introduction to the Amazon Marketplace and provides a training ground for...

  • Prod Compliance Associate Sr, Selection Validation

    2 weeks ago

    Hyderabad, Telangana, India Amazon Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    DESCRIPTION***"Please note that this job is a seasonal role (FTC) for 12 months on the payroll of Amazon" **** is looking for a smart, enthusiastic, hard-working, and creative candidate to join the Selection Validation team as a Product Compliance Associate Sr. This position offers an exciting introduction to the Amazon Marketplace and provides a training...

  • Sr Associate HR Data Analysis

    2 hours ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    ABOUT THE ROLERole Description:Amgen is seeking a Sr Associate HR Data Analysis (Visier Admin). The Sr Associate HR Data Analysis (Visier Admin) will report to the Associate Director HR Technology.The successful incumbent will have previous Visier reporting tool Admin experience.Roles & Responsibilities:Hands on experience supporting VisierPrevious...