Quality Assurance Manager

G&L are a specialist provider to the healthcare industry for all types of Quality and Regulatory Affairs consultancy work – and we are rapidly growing! Our excellent reputation has been built on tailoring solutions and services to each of our clients, to ensure that their expectations are surpassed, and all their requirements are exceeded.We now have multiple opportunities in our global Quality team, where you could be joining our international team of experienced professionals who manage multiple global projects for a wide variety of clients – from giant pharma to niche biotechs. A day in the life of one of our consultants can be varied and unpredictable – this opportunity would be perfect for someone who thrives when busy, enjoys guiding clients through complex regulatory strategies and is completely solutions-orientated.Key Responsibilities:Provide a robust framework to evaluate the overall health of the Trial Master File (TMF), ensuring quality, completeness, and timeliness in the TMF, driving a culture of compliance and quality.Support TMF health by identifying risks and ensuring compliance with internal and regulatory requirements. Proactively generate, monitor, and analyze TMF findings and trends, and collaborate with the trial team to ensure the completeness and accuracy of the TMF.Build collaborative relationships with trial and cross-functional teams as well CROs to ensure the timely and accurate delivery of TMF-related deliverables.Play a critical role in ensuring compliance with internal and regulatory requirements by conducting or supporting inspection/audit interviews related to the TMF.Ensure that all aspects of the clinical trial comply with relevant regulations, guidelines, and standard operating procedures (SOPs), including but not limited to the International Council for Harmonisation (ICH) GCP guidelines.Plan, conduct, and report on audits of clinical trial activities, sites, and documents to verify compliance with GCP standards. This involves reviewing study protocols, informed consent forms, case report forms, regulatory submissions, and other essential documents.Plan, conduct, and report on audits of clinical vendors to ensure they meet GCP standards and contractual obligations.Responsible for identifying compliance risks, proposing solutions and ensure adherence to current GCPs, G&L Guidelines and industry standards.Role has a vital contribution to the management of the quality system, company compliance and will routinely interface with Regulatory Authorities and corporate/third party auditors; activities must be appropriately developed and executedResponsible for managing the CAPA system and lifecycle for regulatory inspections and audits, including finding responses and associated corrective actions; interaction with various levels of the organization both locally and globally required.This position requires a strong understanding of applicable GCPs, as relates to quality assurance in different phases of clinical drug development, as well as current industry standards; this is critical to supporting inspections/audits and ensuring appropriate development of CAPAs stemming from inspections/audits and deviations, as well as for process improvement.Incumbent must be effective in working collaboratively with a variety of personnel/experts from all internal GxP-related departments and other quality functions (both locally and globally), as well as possess a high level of organization at both individual and team levels; these aspects are critical to ensuring smooth inspection life cycle and quality system management.Strong verbal and written communication and technical writing skills are needed in order to prepare accurate, clear and comprehensive documents/communications.Incumbent will be required to interact with a broad spectrum of personnel, including external regulatory bodies, corporate and third-party auditors, therefore also drawing on all of the above skills/knowledge.