Karin Kaiser

Define the audit universe & risk based audit strategy Create and maintain global GCP audit programs Manage the vendor qualification program Lead complex global GxP audits for all phases of clinical studies, suppliers, systems and documents. • Analyze audit and inspection data. • Provide GCP expertise to internal and external customers, proactively maintaining cognizance of current GxP standards. • Lead or support regulatory inspections (and preparations for), as requested. • Develop more junior staff.

Ensuring that quality assurance activities in the GCP area are conducted in accordance with company policies and procedures including applicable regulations and guidelines. Tasks: GCP auditing Incl. 3rd Party vendor qualification and CAPA Management. Mock inspections. Creation and review of company's GxP related procedural documents. Quality Issue Management. Clinical Trial Risk Management.

Lead, develop + manage GCP compliance managers through coaching, guidance and mentorship/Self-assessment+gap analysis to identify business process+systems deficiencies/Design + deliver continuous improvement solutions for business processes + technical solutions+systems/Inspection readiness activities in collaboration with Clinical QA/Conduct Operational Oversight Visits and pre-inspection visits at investigational sites/third vendors /Guidance on regulations, GCP, guidelines

Transformation/change management; GAP analysis on business processes+systems; Design and implement improvement solutions for processes and systems; Analyze, and leverage quality indicators and data to identify potential trends and risks; Quality issues management; Inspection readiness and CAPAs; Guidance on regulations and GCP; Support and manage HA inspections and audits; Conduct internal reviews, investigation of identified compliance issues, and co-monitoring/assessment visits at investigator sites.

Ensure quality and compliance through performing analysis of audit/inspection results. Guidance in root cause analysis and developing CAPAs. Monitor CAPA status. Coordinate and support HA inspection and audit activities in close collaboration with Clinical QA. Ensure consistent approach / response to inspection and audit findings across clinical trials and programs. Participate in process improvement initiatives. Take part in the revision of SOPs, Work instructions and forms,templates and guidelines.

Ensuring that quality assurance activities in the GCP area are conducted in accordance with company policies and procedures including applicable regulations and guidelines. Tasks: auditing, consulting and educating company internal and external (contracted and licensed) business operations. Creation and review of company's GxP related procedural documents.

Manage the execution of assigned global and regionally-based studies, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed on time and within budget and in accordance with SOPs, policies and practices. Manage and co-ordinate efforts of cross-functional project teams, develop study management plans, serve as primary project contact with Sponsor.

As team lead clinical operations apply research expertise in monitoring and site support, through directly working with CRAs, site and study staff, ensuring process and practice methodology is applied consistently and in accordance with SOPs, policies, GCP and regulatory requirements. Conduct co-monitoring visits to manage data backlog, site compliance and quality issues. Act as mentor and coach for CRAs. Participate in recruiting and hiring of personnel in collaboration with line management.

Main contact with sites, performing site visits from selection to close-out, evaluates and ensures patient safety, data quality, adherence to the protocol and agreed SOPs.

Main contact with sites, performing site visits from selection to close-out, evaluates and ensures patient safety, data quality, adherence to the protocol and agreed SOPs. From Jan to June 2009 regional Clinical Team Lead: management of the clinical component of a trial by conducting and tracking key items - budget, training, site visits, data quality, safety issues and protocol deviations. Close cooperation with project manager and other project leads.

Main contact with sites, performing site visits from selection to close-out, evaluates and ensures patient safety, data quality, adherence to the protocol and agreed SOPs.

basic research in molecular biology and pharmacology. Setup and maintenence of collaborations with other research groups.

Total quality management including management of annual reviews, internal audits, scheduling and attendance of certifications/accreditations by external sites