GCP Consultant GCP Auditor

1 month ago

Raleigh, United States Adamas Consulting Full time

Job Description

  • Independently oversee and manage multiple audit programs while maintaining compliance with applicable processes and procedures

  • Successful Leadership and oversight of external contractors with a dedication for building strong relationships

  • Demonstrates Excellence in Project Management through the successful provision of quality deliverables; generation and maintenance of project governing documentation and plans; oversight of key performance indicators (KPIs) and Key Quality Indicators (KQIs); while maintaining compliance with contract requirements and financial agreements.

  • Resource and maintain the audit programs and schedules

  • Planning, preparation, conduct, reporting and follow up of various types of GCP audits according to expected quality and timelines

  • Executing audits based on a comprehensive understanding of all regulatory requirements and Good Clinical Practice (GCP).

  • Performing GCP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.

  • Assisting with business development activities



    Qualifications:
    Qualifications

  • Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site. BSc in Life Science preferred

Experience in conducting and leading internal and external GCP audits for a variety of stakeholders

Experience in conducting a range of service provider audits (e.g., investigator site audits, full-service CRO, phase I)

Experience in conducting GCP systems audits.

Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage.

Expert knowledge of national and international GCP legislation and guidelines

Up to 40% travel and ability to conduct remote audits

Additional Information

Why ADAMAS?

As an organization, we prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? Because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

Training and career development opportunities internally

Strong emphasis on personal and professional growth

Friendly, supportive working environment

Opportunity to work with colleagues based all over the world, with English as the company language.

Our core values are key to how we operate, and if you feel they resonate with you then ADAMAS, an Ergomed Company is a great place to join

Quality

Integrity & Trust

Drive & Passion

Agility & Responsiveness

Belonging

Collaborative Partnerships

We look forward to welcoming your application.



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