R&D Quality GCP Auditor

Amgen; Portugal; Híbrido; EUR 50 000 - 70 000; Tempo integral

Resumo da oferta

A global biotechnology firm in Portugal is seeking an experienced R&D Quality GCP Auditor. You will plan and conduct GCP compliance audits internationally, serve as a lead auditor, and support regulatory inspections. The ideal candidate has a Bachelor's degree in a scientific discipline and extensive auditing experience. The role involves up to 40% travel. Join us to innovate in healthcare through technology.

Serviços

Generous Total Rewards Plan

Flexible work arrangements

Opportunities for learning and development

Qualificações

• Extensive experience in GCP auditing.
• Regulatory authority inspection experience preferred.
• Postgraduate qualification is advantageous.

Responsabilidades

• Plan and conduct GCP compliance audits internationally.
• Serve as a lead auditor for complex GCP audits.
• Identify compliance risks.
• Host regulatory authority inspections.
• Contribute to R&D Quality process improvements.

Conhecimentos

International auditing conduct experience in GCP

Data mining and analytics

Excellent written and verbal English communication

Formação académica

Bachelor’s degree in a scientific discipline

Descrição da oferta de emprego

Overview

Join our team at Amgen Capability Center Portugal, the #1 company in Best Workplaces™ (201–500 employees category) by the Great Place to Work Institute. With over 400 talented individuals from more than 40 nationalities, our Lisbon center thrives at the intersection of innovation, excellence, and inspiration. This is your opportunity to explore the future of healthcare through technology and digital innovation, supporting our mission To Serve Patients.

R&D QUALITY GCP AUDITOR

LIVE

Responsibilities

What you will do

You will be joining Amgen’s R&D Quality Audit Team of expert, professional and widely experienced individuals working with a global remit across Amgen’s portfolio in all stages of development and post marketing. The R&D Quality audit team is part of Amgen's R&D Quality Group.

In this vital role as R&D Quality GCP Auditor within R&D Quality you will be planning and participating in global audits of Amgen’s clinical trials activities. You may also support regulatory inspections of clinical sites and Amgen facilities.

Key responsibilities include:

• Plan, conduct and report routine and directed GCP compliance audits internationally
• Serve as a lead auditor for complex GCP audits
• Identify and communicate compliance risks to R&D Quality management
• Host and/or play a role in regulatory authority inspections
• Contribute to or lead R&D Quality process improvement initiatives
• Author and contribute to the development of R&D Quality cross functional controlled documents

The role can entail up to 40% travel to international destinations.

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:

• Bachelor’s degree in a scientific discipline, medical sciences or pharmacy qualification
• Extensive international auditing conduct experience in GCP or as regulatory authority inspector
• Experience of data mining, manipulation and data analytics would be advantageous
• Excellent written and verbal English communication skills

Preferred Requirements

• Postgraduate qualification
• Experience supporting regulatory authority inspections
• Participation in process improvement initiatives

Thrive

What you can expect of us

• Vast 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.

Apply now

APPLY NOW

Objects in your future are closer than they appear. Join us.

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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 ensure that individuals with disabilities are provided a 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 an accommodation.