Dr. Marika Jocksch-Mützelburg

• Manage implementation of quality standards, processes, tools and systems used in conducting due diligence/integration for in licensing, merger & acquisition and out-partnering projects across GxP areas in Global development Quality (GDQ) • Responsible for QA due diligence activities and related integration across GDQ • Contribution to BD&L Quality Review Boards, responsible for collection and reporting of KQIs and status of associated quality remediation/action plan negotiations

• Preparation and execution of Self-Inspections for device departments as Lead-/Co Auditor • Project Lead of 3rd party management program • Creation of purchasing control processes • Execution of Supplier Audits as Lead-/Co Auditor • Support of Health Authority and Customer Inspections for Device Development • Creation of 3rd party statistics • Data integrity specialist (person of contact for DI related questions or challenges) • Training of SMEs

• Preparation and Realization (front and back room) of Health Authority and Customer Inspections • Project Lead of the Health Authority Readiness Programs • Participation of Health Authority Inspection (AGES, Cofepris, FDA, MoH Turkey) • Participation on internal inspections • Creation of deviation and CAPA statistics • Performance of inspection walkthroughs • Training of SMEs

• Range of methods: CE, HPLC, ELISA, gel electrophoresis, several analytical methods • Development and validation of IPC methods • Execution of ICP and Release measurements for the running production • Ensuring the quality standards in the cGMP environment • HSE responsible • Management of 3-5 team members • 2010: Trainer in chemical analysis on WIFI Tirol for the course for foremen

• area of concentration: Toxicology & Mass spectrometry • Thesis: „Quantitative Proteomanalyse of human Neuroblastoma-cells using LC-MALDI techniques“ (methods: CE, HPLC, Nano-LC, 2D-technics, MALDI, ESI, cell culture)

Foresic Chemistry & Analytics / Bioanalytics Thesis: „Trennung isomerer Phosphopeptide mittels Kapillarelekrophorese und Chromatographie“ (“Separation of isomeric phospho-peptides using capillary electrophoresis and chromatography”; methods: CE, LC, HPLC, MALDI, ESI, gel electrophoresis, ELISA)