Gap assessments and risk-based continuous improvement.GCP auditing, internal system audits, and hosting and responding to sponsor audits.Computer system validation, computerized systems.Root cause analysis, risk assessment, and development/management of effective CAPAs and associated systems.Quality management system development and management, including writing of standard operating procedures.Prior experience and competence with the following areas:.
QARC SYSTEM FULL
The ideal candidate will be a strong quality assurance “generalist” comfortable with managing the full spectrum of quality assurance responsibilities, establishing new systems, adjusting to the scale of a small niche vendor, and finding creative, realistic solutions to compliance that fit an established organization.At least 3 years of direct GCP auditing experience. 5-8 years in the pharmaceutical or biotech industry, at least 5 years of which must be in a quality assurance management or director level.BA/BS in associated functional discipline.Perform other duties and/or projects as assigned.Adapt to new responsibilities and duties as required.Maintain a working knowledge of ICH GCP guidance, FDA, EU, UK and applicable regulations, including privacy requirements.Host and manage sponsor audits and regulatory inspections support cross-functional development of communications and CAPAs in response to audits and inspections.Develop audit plans and perform audits and assessments of internal systems guide direct reports and potentially leverage non-QA staff to assist in audits and assessments.Apply risk-based decision making through all facets of the job.Develop, deliver, and/or manage training for colleagues on quality assurance topics and written procedures.Ensure inspection readiness by performing and/or addressing gap assessments and initiating continuous improvement projects.
Guide the cross-functional development of written procedures in alignment with applicable guidance and regulations establish and implement quality policies and procedures.Develop and lead the GCP quality organization, coaching and mentoring direct reports.Ensure organizational operations are compliant with GCP and applicable FDA, ICH, EMA and industry requirements and standards.Promote a culture of continuous improvement, and cross-functional problem-solving.Leverage expertise and experience to provide interpretation of GCP and applicable regulatory regulations and/or guidelines.Provide quality oversight of internal operations.Provide leadership and oversight to quality assurance department, working alongside peers and direct reports to ensure the implementation of a robust quality management system and structure.The Director will implement a risk-based quality management system that encompasses quality control and quality assurance across all services that QARC provides. The Director will work closely with clinical operations, information technology, physics and dosimetry and other supporting areas/development teams, to help ensure active participation in continuous quality improvement activities. The Director, Quality Assurance QARC will lead and grow QARC’s quality assurance group and provide a strong foundation of GCP expertise to ensure the development and management of a comprehensive, compliant quality management system.
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