Dirk Halle

Workstream Lead and Key Account Manager overseeing Quality Assurance matters pertaining to product divestments, discontinuations, and strategic partnerships within the New Business & Alliances Unit. Accountable for the drafting, negotiation, and management of Quality Agreements (QAAs) throughout their lifecycle with asset buyers and partners. Additionally, responsible for implementing, executing and monitoring internal processes at GSK to ensure ongoing compliance with QAA requirements.

SPOC for all Quality Assurance and Regulatory Affairs topics between the site, a global divestment business unit and the buyer within a product divestment project. QA oversight for technology transfer activities (incl. drug substance, drug product, packaging and QC) to the buyer or CMOs chosen by the buyer. QA-SPOC for industrial customers.

Ensuring compliance with cGMP, internal policies and applicable regulatory requirements by leading a team of 12 Process Specialists responsible for change control, deviation investigation, validation support and inspection readiness of GSK Marburg’s Bacterial Operations department.

Active contributor for the Marburg manufacturing site within GSK Vaccines’ global regulatory affairs matrix organization for the preparation of regulatory dossier submissions to health authorities. Performing regulatory impact assessments of facility and equipment change controls for EU, USA, CAN, JP, ROW.

Planning, budgeting and leading of projects for Marburg’s process unit “Center of Sterile Supplies”. Change Control Manager for GSK Marburg’s sitewide container renewal project. Workstream lead (incl. lateral leadership of a team of 6) for change controls during Marburg’s integration into GSK’s ERP system.

Fellow of Novartis Vaccines and Diagnostics "Technical Leadership Program" with placements incl. • Warehousing and distribution • Vaccines drug substance manufacturing • Excipients and adjuvants manufacturing • MSAT for formulation and filling

Intern at Novartis Biologics, Media and Process Development Pilot

Biotechnologie, Bioverfahrenstechnik, Biokatalyse