Stefan S. Email & Phone Number

Boston, Ma, Us

Cambridge, Ma, Us

Cambridge, Ma, Us

Boston, Ma, Us

 Coordination and Oversight of Vendor Audits  Facilitation of planning, scoping and debriefing meetings with Vendor  Review of Audit reports, responses, and CAPAs  Report Issuance  Oversight of Response, CAPA and EC monitoring / follow-up by Vendor  CAPA follow-up and review Conduct of vendor audit as assigned  Onsite participation  Directed/For-Cause audit participation Leadership and/or participation in process improvement projects both within Clinical QA as well as more broadly Identification, triage, escalation, reporting and investigation of events; may serve as Event Initiator, Event Owner, and/or CAPA Owner. (ex. Serious breach, Deviation, Audit finding, CAPA, EC)  Metrics generation and reporting as requested using manual/paper based process Inspection Support-Provide onsite front and/or back room inspection support as assigned Identification and reporting of potential gaps/risks to quality system owners Knowledge of ICH-E6 Knowledge of 21 CFR Parts 11, 56, 312, and 314

Arlington, Massachusetts, Us

 Provide input into the development and maintenance of master audit plan for Clinical Programs Ensure the audit plan is implemented to provide assurance that clinical studies managed in compliance with the requirements of Kala’s SOPs, study protocols, relevant regulations, and ICH/GCP guidelines Ensure that audit results are formally and consistently recorded, reported, monitored, trended, and to also ensure that corrective/preventive actions have been established and documented effectively Manage vendors and CROs during external and internal auditing Support QA functions related to GxP activities Develop, review, and approve company documentation  Support vendor qualifications per Kala SOPs. This includes audits of GCP, GLP, and GMP. Perform batch record review for products manufactured by third parties Review investigations and provide input into CAPAs. Track investigations to ensure closure. Maintain employee Training for GxP activities Help implement electronic QMS.

Cambridge, Ma, Us

 Provide input into the development and maintenance of master audit plan for Clinical Compliance Ensure that the audit plan is implemented, in order to provide assurance that clinical studies managed by Sarepta are of the highest quality standard and are in compliance with the requirements of Sarepta SOPs, study protocols, relevant regulations and ICH/GCP guidelines Ensure that audit results are formally and consistently recorded, reported, monitored, trended and also ensure that corrective/preventive actions have been established and documented effectively Manage vendors and CROs during external and internal auditing Development, training and maintenance of Clinical SOP’s and Training Matrix Audit (trial master file, CSR’s, Protocols, submission documents etc.) ICH/GCP training at investigator meetings and internally  Clinical Inspection Readiness Assist in GLP Facility, testing site and study audits as required Assist in maintenance of audit files and qualified vendor list

Durham, Nc, Us

Experience in lead auditing for validation protocol/ validation report, bioanalytical sample analysis plans/reports, data and in process audits. Computer System Validation Lead for Luminex, Artel Pipette Calibration Syste, MSD Workbench and worked on validation projects for SoftMax Pro GxP, ViiA 7, Compliance Wire, Cellometer Auto 2000, and QUMAS ComplianceSP. Experience in writing and editing validation protocols, IQ/OQ/PQ, user requirements, traceability matrixes, and validation reports. Change control agent, CAPA and process improvement expert. Support improvement and remediation projects, provide input to ensure streamlining of processes, review and edit SOP’s, policies, protocols, reports and work instructions. Knowledge in IVD, LDT, clinical diagnostics and bioanalytical method validations. EDMS experience with QUMAS ComplianceSP, beta tested and validated closely with QUMAS, as well as experience with NextDocs and Sharepoint 2010. Expert user of Microsoft Office Suite (Word, Excel, Outlook, and PowerPoint), Microsoft Share Point Enterprise 2010 and Adobe Acrobat 9. Document scanning, rendering, bookmarking/linking, and document formatting.

Durham, Nc, Us

Durham, Nc, Us

South San Francisco, California, Us

Provided Quality Assurance role for patient data being reported to Genentech. Active participant in the data collection and quality assurance component of a clinical research study on the use of Cathflo in the care process for home-health care and hospital patients with central venous access devices. Reviewed primary data, patient charts, and other data collection venues to ensure accuracy, consistency and quality of data.

Malvern, Pa, Us

Provided Quality Assurance role for patient data being reported to Endo Pharmaceuticals. Conducted primary research with patients via telephone interviews to determine their receptiveness to new products and alternative drug delivery systems. Analyzed results and provided a summary report to the Endo Pharmaceuticals product development team to help them understand patients’ opinions about their products.

Master'S Degree, Regulatory Affairs And Heath Policy

Bachelor'S Degree, Health Science

Education record