Develop and implement quality management plan for the program Interpret key metrics and provide the information to the Global Product Team Leader and cross-functional development team members Support GCP SOP development and serve as a quality operations reviewer Execute client's risk-based methodologies for the planning and execution of clinical protocols. Manage quality issues, including audit reports, quality issues/incidents and CAPA development per client's GCP protocols. Facilitate closure of quality issues, including CAPAs per client's protocols. Facilitate the assessment and investigation of quality issues, utilizing expertise to provide recommendations and drive root cause analysis and remediation. Provide appropriate escalations and notification to line management per client's GCP protocols. Lead GCP inspection readiness and inspection preparation activities, including SME training and preparation. Analyze the risks and propose the strategy for readiness and manage the implementation of GCP readiness program. Conduct and document assessment of inspection readiness procedures, provide gap analysis recommendations for remediation and/or improvement. Provide lessons learned after each GCP inspection. Provide guidance on GCP and clinical development compliance issues to business partners. Manage temperature excursions occurring during shipment and site/patient home storage. Collaborate with partners in Global Clinical Supply and Good Manufacturing Practice (GMP) QA to address excursions. Mentor other Clinical Quality Operations Quality Leads Partner with development team(s) to improve Standard Operating Procedure (SOP) compliance within the team(s). Prepare Medical Device Considerations Guidance for Study Teams (including checklist tool to leverage in inspections readiness effort). Support “Device Requirements” training content development. Deliver content assessment report on training:
Perform assessment of current Quality support provided by the study team across R&D Quality (GCP) and Global Operations Quality (GMP) with the aim of streamlining interactions and developing recommendations for closing any gaps. Assist in recruiting efforts for Quality Operations Lead (with relevant device experience) and help with transition of responsibilities once onboarded.
The Consultant will provide the following deliverables at the direction of client as time allows during the course of this engagement:
-A quality management plan for the program
-A documented assessment of inspection readiness procedures, including gap analysis recommendations for remediation and/or improvement
-A Medical Device Considerations Guidance for Study Teams document (including checklist tool to leverage in inspections readiness effort)
-A content assessment report on training
-Perform assessment of current Quality support provided by the study team across R&D Quality (GCP) and Global Operations Quality (GMP) with the aim of streamlining interactions and developing recommendations for closing any gaps
-Assist in recruiting efforts for Quality Operations Lead (with relevant device experience) and help with transition of responsibilities once onboarded
9+ Years of Experience
Minimum of 8 years’ of experience pharmaceutical or biotechnology drug development experience
Experience managing clinical quality activities and knowledge of clinical operations
Comprehensive knowledge of all pertinent regulations
Excellent communication, negotiation, and customer service skills.
Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment.
Results oriented; able to determine approaches to assignments. Strong interpersonal skills while building/keeping/monitoring quality and compliance. Problem-solving skills with ability to analyze situations and/or data while considering future impact and intangible variables.