Clinical Quality Asurance consultant

Company Description

Biotech Consulting Group is an award-winning, data-focused consultancy that supports pharmaceutical, biotech, and medical device organizations with a scientific approach to complex clinical trial data and regulatory submission challenges. The group combines deep industry experience with advanced analytics to guide clients through all stages of drug and device development. By focusing on data integrity, evidence generation, and regulatory readiness, Biotech Consulting Group helps teams build compelling submissions that meet rigorous global standards. The organization values collaboration, critical thinking, and high-quality outcomes, offering consultants the opportunity to contribute to impactful therapies and innovations. Professionals joining the group can expect a dynamic environment working with diverse clients and cutting-edge clinical programs. Role Description The Clinical Quality Assurance Consultant will provide expert QA support across clinical trials, ensuring compliance with GCP, internal SOPs, and applicable regulatory requirements. This contract role is fully remote, collaborating with cross-functional teams in clinical operations, data management, pharmacovigilance, and regulatory affairs. Day-to-day responsibilities include planning and conducting quality audits of clinical sites, vendors, and trial-related systems; reviewing key study documents (protocols, informed consent forms, monitoring plans, and TMF content) for accuracy and compliance; and tracking quality issues through to resolution. The consultant will develop and refine QA processes, risk-based monitoring strategies, and CAPA plans, while advising project teams on best practices and regulatory expectations. The role also involves preparing for and supporting regulatory inspections, writing clear audit reports, and providing quality training and guidance to project stakeholders.

Qualifications

Clinical quality assurance expertise, including GCP, ICH, and regulatory guidelines, with experience auditing clinical sites, CROs, and vendors. Strong clinical trial operations understanding, including protocol implementation, monitoring processes, TMF management, and safety reporting workflows. Proficiency in risk-based quality management, root cause analysis, and development of CAPAs to address operational and compliance issues. Experience supporting regulatory submissions and inspections (e.g., FDA, EMA), including preparation of documentation and inspection readiness activities. Ability to interpret and apply SOPs, policies, and regulatory requirements to diverse studies in pharma, biotech, or medical device settings. Excellent written and verbal communication skills, with the ability to produce concise audit reports and provide clear quality guidance to cross-functional teams. Strong analytical, organizational, and time-management skills, with demonstrated ability to work independently in a remote, consulting environment. Bachelor’s or advanced degree in life sciences, pharmacy, nursing, or a related discipline; relevant QA or GCP certifications are an advantage. Several years of clinical quality assurance experience in industry or consulting, ideally across multiple therapeutic