Danny De Scheemaecker Email & Phone Number

China

Responsible for operations and performances of the CMC Quality Assurance (QA) Departments of the Shaoxing and Tianjin SM API sites in China.Oversee the QA Departments routine operations to ensure in compliance with Current Good Manufacturing Practices (cGMP) and other regulatory requirements.Lead the QA teams working cross-functionally with R&D, Process, Procurement, Manufacturing, Quality control, logistics and other relevant functions linked to the small molecule API manufacturing activities worldwide within Pharmaron to maintain quality standards for compliance, and to ensure supplying high quality product and patient safety.

Belgium

Responsible and accountable for leading proactive risk management, managing high profile EM (external manufacturer) compliance programs, and implementation of a streamlined EM follow up process. Serve as Regulatory Compliance advisor on compliance strategies across the external Supply Chain of the J&J Innovative medicines unit.

Belgium

Provides Quality Assurance, Compliance and Management oversight on quality management activities for Suppliers and External Manufacturers world wide that are linked to an improvement project to optimize the internal SM API capacity.Provides leadership in the selection, development and management of Suppliers and External Manufacturers in the different regions with indirect managment of internal quality professionals. Contributes to the overall development, implementation and execution of quality systems in support of the material sourcing and manufacturing.

Belgium

Direct all of the Quality and Compliance activities related to External Manufacturers (EMs) for SM API worldwide. (API starting materials, GMP intermediates and APIs)Coach, train, lead a worldwide team of managerial supplier quality professionals. Steers and organizes quality activities with External Manufacturers including quality agreements, deviations, investigations, change control, product transfers, risk assessments and recalls.Implementation and follow-up of the quality systems at the EMs, to assure full compliance with internal and regulatory policies and guidelines (including indirect management of their quality management and organization)Preparation and support during pre-approval and general cGMP inspections by the authorities at the EMs.

Belgium

Direct all of the Quality and Compliance activities related to suppliers and External Manufacturers in the Asia Pacific region for suppliers of API, Excipient, Packaging materials, Components and BIO materials. Coach, train, lead and develop the regional quality professionals team in ASPAC.Steers and organizes quality activities with Suppliers and External Manufacturers in ASPAC including quality agreements, deviations, investigations, change control, product transfers, risk assessments and recalls.Implementation and follow-up of the quality systems at the EMs and suppliers, to assure full compliance with internal and regulatory policies and guidelines (including indirect management of their quality management and organization)Preparation and support during pre-approval and general cGMP inspections by the authorities at the EMs and suppliers.

Belgium

Responsible and accountable for the quality of the products produced by the EMs and suppliers in Asia and supplied to internal supply chain sites (release, deviation handling, change management, validation)Implementation and follow-up of the quality systems at the EMs and suppliers, to assure full compliance with internal and regulatory policies and guidelines (including indirect management of their quality management and organization)Preparation and support during pre-approval and general cGMP inspections by the authorities at the EMs and suppliers sites.

Belgium

Planning, execution and follow-up of internal audits within the chemical production of Janssen BelgiumPlanning, execution and follow-up of external audits at suppliers and external manufacturersPreparation, accompany/guide and follow-up of site inspections (inspections by customers and health authorities)Responsible for supplier qualification

Belgium

Development and implementation of a fully automated robot system for specific formulations, in co-operation with different external companies (including price negotiations)Development and training of a global Janssen specific HPLC training course (5 days training course) Development training manual of a global Janssen specific GC training within Janssen Beerse, Geel and OlenSupport and coaching development and implementation GC training within the chemical quality control departmentDevelopment and training of chromatographic techniques for new employees (QA and QC)Validation new Purified Water system in chemical production Geel Belgium ( + composing and co-ordination of a dedicated team of analysts, planning and budget, contact person for engineering and microbiology lab)Part 11 validation of analytical equipment (selection, development and validation) Selection, implementation and validation of a new Chromatographic Data System within Chemical quality control departments at 3 sites in Belgium. ( + composing and co-ordination of a dedicated team of analysts, planning and budget, price negotiation with suppliers)Analytical transfers to internal Janssen sites and external suppliersSupporting and coaching of theses of senior students

Belgium

Daily management of a team of 7 analystsManagement lab-activities: o Planning (production – lab)o Review en validation of test-resultso Calibration and maintenance activities

Belgium

Execution of analytical tests (wet –chemical and chromatographic testing) Repair, maintenance and calibration of analytical instruments

Middle Management

Bachelor'S Degree, Chemistry

Education record