Sr Associate Quality Compliance

1 day 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.

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