Are you an experienced, high-quality, professional who is interested in joining a team of collaborative colleagues, working together to bring quality assurance and quality management services to the forefront of the pharmaceutical industry?
Our Good Clinical Practice (GCP) team of experts assist our clients in identifying the risks in their systems and processes so they can take decisive action in continuous improvement. Through the use of our extensive experience and knowledge, we help safeguard clinical development programs, bringing life-changing therapies to market faster and safer.
As a GCP Consultant, you will be responsible for planning and conducting GCP audits and clinical Mock Regulatory Inspections for our clients in line with the ADAMAS values in quality, integrity, and excellence.
Your responsibilities will include the following:
- Executing audits based on experience and a comprehensive understanding of all federal regulatory requirements and guidance on Good Clinical Practice (GCP).
- Performing GCP quality assurance projects which fall within your areas of expertise on behalf of client companies within the pharmaceutical/biotechnology industry
- Contributing to the upskilling of consultants in the conduct of vendor and systems audits
- Actively participating in the ADAMAS Learning Management System (LMS)
- Assisting with business development activities
- Performing other reasonable duties as requested by the job holder’s Line Manager
Remote, Flexible, Full-Time Role
This role is an immediate, full-time employment opportunity for an ambitious individual who is looking to serve as an industry expert, gain international experience and broaden their skills. Personal development is a priority for us at ADAMAS, and we encourage our team to expand their knowledge at every opportunity.
At ADAMAS we believe the best impact is the value we add for our clients, not hours spent in the office and so this role is fully remote (with some requirement to travel for on-site audits/inspections) and flexible. Tell us what arrangement works for you and we’ll try to accommodate your needs.
We are committed to providing all our clients with the highest level of service in every country and as part of our APAC team, you will need to be based in India.
Your professional experience
- Master’s Degree in Life Science Preferred
- 5 years of experience conducting and leading internal and external GCP audits for a variety of stakeholders globally
- Experience in conducting a range of service provider audits (e.g., System, full-service CRO, biostatistics, data management, phase I)
- Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site for various regulatory authorities (e.g., CDSCO, EMA, US FDA, MHRA, etc.)
- Experience in conducting GCP mock inspections to various Competent Authority standards
- Expert knowledge of ICH E6 (R2), NDCT Rules 2019 and other international regulations and guidelines as applicable
- Proficient in managing projects and ensuring deliverables are provided on time
- Excellent oral and written communication skills
- Ability to identify issues and offer solutions in a pragmatic way
Other Skills and Requirements:
Our people and the way we work set us apart. We work closely with our clients, providing industry-leading innovation and knowledge to deliver solutions that add genuine value to their business.
We place great worth on development and collaboration so we can best succeed together. When needed we also place great importance on intellectual curiosity and the ability to work autonomously.
To succeed in this role you will need:
- Strong communication skills
- Excellent writing skills
- Positivity, flexibility, and adaptability
- Highly professional and self-motivated
- Ability to work independently in a home office setting
- Confidence to work alone or in a team
- Up to 40% global travel and ability to conduct remote audits
About ADAMAS Consulting
ADAMAS Consulting has been leading the industry for over two decades, conducting audits in all therapeutic areas in over 100 countries. By applying critical thinking to solving compliance issues as pragmatically and efficiently as possible we continuously innovate to meet the challenges of the ever-changing clinical landscape.
Our Benefits Package Includes
- Competitive salary that reflects experience and contribution
- 20 Paid Vacation Days
- Flexible working hours designed to help you succeed
- Training across GxP’s from the industry’s top experts
- A structured development plan to help you grow in your role with scope for upward movement
- Work from home
Our Recruitment Process
At ADAMAS Consulting we believe that diversity of experience can only contribute to a broader collective perspective that will consistently lead to a better company and better service. We are committed to always promoting equal opportunities in employment. All job applicants will receive equal treatment regardless of age, disability, gender identity, sexual orientation, race, religion or belief, education, or socioeconomic background.
We do everything that we can for our recruitment process to be fair and inclusive, so please do let us know if there are any reasonable adjustments we can make.
How to Apply!
If you like the prospect of a home-based role, flexible working conditions, excellent benefits and of course the opportunity to further your career within an exciting organization, then please submit your CV to Sheri Arone at email@example.com.
No unsolicited calls from recruitment agencies please.