Regulatory Affairs - Medical Device

A Pharmaceutical client is looking for a Senior Quality Assurance Specialist , specifically with documentation experience in biotechnology or pharmaceutical industry

GCP Quality Assurance will provide expertise and guidance on Good Clinical Practice (GCP), applicable regulations to clinical and nonclinical development teams to proactively identify compliance issues/risks and recommend mitigation. They will work with internal clinical functions and external parties including consultants, contract auditors, CROs and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for all programs. Will manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems in compliance with GCP, and company policies and procedures; assess impact of audit. They will support a culture of sustainable compliance; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready.

Experience

Bachelor’s degree in a scientific discipline is required. Advanced degree preferred.7+ years of clinical trial experience in a pharmaceutical, biotech, hospital setting, or a CRO is required with at least 5 years managing clinical trials.Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development

Responsibilities

Provide expertise in GCP, compliance interpretation, consultation, training, and recommendations to clinical development functions and program teamsLead investigations into significant quality issues, scientific misconduct and suspected serious breach of GCP or GLP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate. Manage deviations and CAPAs through completionIdentify and mitigate GCP activities and process improvement initiatives as requested by managementWork closely with Quality Assurance Head to ensure alignment and compliance with Wave Quality SystemsProvide risk identification/mitigation support for potential or identified quality issuesAppropriately escalate any quality/compliance issues to relevant leadershipPerform a quality assurance review of documents and data intended for regulatory submissionPerform quality assurance and GCP compliance review of various clinical study documentation such as study protocols, ICFs, monitoring plans, clinical study reports, etc. Create, revise and review of GCP systems related SOPs to assess their adherence to applicable regulatory standards and corporate goals. Create and give training as needed Assist in the development, tracking, and reporting of quality metricsParticipate in GCP health authority inspections as requiredParticipate in due diligence activities and process improvement initiatives as requested by management Maintain compliance with all company policies and proceduresPerform and participate in auditsPerform related duties as assigned by supervisor