GCP Consultant (GCP Auditor) - Adamas Consulting
Raleigh, NC
About the Job
ADAMAS is a well-established, leading provider of mission-critical regulatory compliance and consulting services to the global pharmaceutical industry. It operates across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computer Systems Compliance (CSC) (together, GxP).
Founded in 2007, ADAMAS has focused on ensuring that the highest standards of best practice are attained across the pharmaceutical sector. ADAMAS has an established client base with an expansive global reach, including North America, Europe, and Asia Pacific. We work with over 100 currently active clients and have worked with over 700 pharmaceutical companies, including 40 of the 50 largest global pharma and biotech companies.
At ADAMAS, our people are our primary asset. We possess the highest and broadest level of in-house knowledge and can deliver genuine expertise and experience globally via in-house resources. ADAMAS's success is down to the calibre of its people – to reward them we offer a competitive salary with benefits, excellent working conditions and a fulfilling and rewarding career, with plenty of opportunities for further development.
Job DescriptionIndependently 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
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.
