GCP Consultant, Asia

Job Title

GCP

Location

Remote (India)

Salary

9.3 lakhs INR

About Us

Join our dynamic and innovative consulting team, where we’re committed to fostering an inclusive environment and delivering exceptional quality in the biopharmaceutical space. We pride ourselves on being the go-to experts in quality assurance, driving impact and innovation every day.

Position Overview

We're looking for a highly skilled and approachable Consultant with a deep understanding of Good Clinical Practice (GCP). You'll help our clients in the biopharmaceutical industry maintain the highest standards of quality and regulatory compliance throughout the clinical development lifecycle. This role involves close collaboration with cross-functional teams, a keen eye for detail, an in-depth understanding of GCP compliance in clinical trials, and a genuine passion for patient care.

Key Responsibilities

• Develop and Review GCP-Compliant Documentation: Create, review, and approve essential clinical documents, including Standard Operating Procedures (SOPs) for clinical trials, study protocols, informed consent forms, clinical study reports, and other relevant trial records. You'll ensure these documents align with global GCP regulatory requirements and industry best practices.

• Conduct GCP-Focused Audits: Lead and execute audits of internal processes, clinical trial sites, and external vendors (e.g., CROs, labs) to verify strict adherence to GCP. These audits will assess the integrity of clinical data, adherence to protocols, subject and IMP records, and overall trial conduct. Audits may be conducted virtually or in-person.

• Analyze Quality Trends in Clinical Operations: Identify and analyze quality trends specifically related to clinical trial conduct, data management, and system validation. You will provide actionable insights and recommendations for continuous process improvement to enhance overall trial quality and compliance.

• Integrate Quality Standards Throughout Clinical Development: Collaborate with project teams to embed quality standards throughout the entire clinical product development lifecycle, from study design through closure. You'll advise on processes and systems that promote data quality, traceability, and regulatory compliance for clinical trials.

• Serve as a GCP Subject Matter Expert: Act as a go-to expert for clinical quality-related inquiries, offering guidance on GCP standards to clients and internal teams. This includes providing expertise on regulatory expectations, interpreting guidelines, and ensuring compliance with frameworks such as ICH GCP, FDA regulations, EU regulations (e.g., ICH E6, 21 CFR Parts 11, 312, 812), and other applicable global requirements.

• Apply Phase-Appropriate GxP Requirements: Ensure adherence to global Good Clinical Practice (GCP) and other relevant regulatory requirements (e.g., GLP, 21 CFR Part 11) across various phases of product development and manufacturing.

• Documentation and Audit Reporting: Meticulously document all client-facing activities, including reviews related to clinical studies and GCP audits. Create comprehensive GCP audit reports detailing findings and potential risks.

• Training and Operational Manual Development: Develop clear and effective training materials and operating manuals for both internal teams and clients. These will cover best practices for maintaining quality and compliance in GCP-driven clinical operations and for executing specific GCP-related procedures.

• Advise in Clinical Trial Documentation: GCP consultant should have an impressive working knowledge of how clinical trial documentation is organized at clinical sites, the role of various GCP personnel in the conduct, oversight, and monitoring of clinical trials (including expectations of CROs)

Other/Supplemental Responsibilities

Continuous Improvement and Ad-Hoc Activities: Engage in additional activities as required, contributing to the continuous improvement of quality systems and regulatory compliance across all client projects, with a

What We’re Looking For

• A minimum of 10 years of experience in clinical quality assurance

• A Bachelor’s degree or a relevant healthcare professional license is required (e.g., Registered Nurse)

• A strong understanding of applicable cGCP regulatory requirements and ICH guidance documents

This may include FDA, NMPA (China), EU, TGA, etc. guidelines

• Prior experience working with companies following FDA regulations is required

• Exceptional organizational skills with the ability to prioritize and meet deadlines

• A great communicator who can break down technical details into simple terms

• A knack for problem-solving and making data-driven decisions

• Excellent English communication skills (IELTS level of 7 or higher)

• Ability to attend client and team calls during US hours

• It is not a requirement to do all work during US hours; only when necessary/recommended

What We Offer

• Flexible remote work environment

• Opportunities for professional growth and development

• Experience with some of the top biopharmaceutical companies and the opportunity to support exciting advancements in medical therapies

• A supportive and down-to-earth team culture

• The chance to make a meaningful impact in a growing, BIPOC-led company

• Benefits (health insurance, dental, vision under Plum India)