GLP/GCLP Auditors

Company Description

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 Description

ADAMAS’s success is down to the caliber 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.

ADAMAS Consulting LLC is an independent provider of GXP Quality Assurance services to the pharmaceutical, biotechnology and healthcare industries. ADAMAS Consulting LLC, established in 2007, is the fully owned US subsidiary of ADAMAS Consulting Group Ltd based in the UK.

Responsibilities:

• Delivery of projects in compliance with agreed project proposals
• Prepare, conduct and report GLP/GcLP system audits for both client and service providers as well as inspection support
• Conduct mock GLP/GCLP inspections
• Perform the role of Project Lead and Client Liaison
• Project management of audit programs
• Delivery of consultancy services e.g., GLP/GCLP system reviews, vendors, gap analysis and ad-hoc consultancy

Qualifications

Requirements:

• BS in Life Science, preferred
• Experience in conducting and leading internal and external GLP/GcLP audits for a variety of stakeholders (e.g., bioanalytical laboratories, central laboratories)
• Experience in conducting a range of service provider audits
• Experience in coordinating and managing inspection preparation activities for GLP/GCLP process inspections
• Experience in conducting GLP/GCLP mock inspections to Competent Authority standards considered a significant advantage
• Acting as subject matter expert to ensure effective inspection preparation management
• Expert knowledge of national and international GLP/GcLP legislation and guidelines
• Proficient in managing projects and ensuring deliverables are provided on time
• Ability to identify issues and offer solutions in a pragmatic way

Other Requirements:

• Strong communication skills
• Excellent technical writing skills
• Proficient in English writing and communication 
• Positivity, flexibility, and adaptability
• Highly professional and self-motivated
• Ability to work independently in a home office setting
• Confidence to work alone or in team
• 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.