Für ein international erfolgreiches Pharmaunternehmen in Oberschwaben suchen wir zum nächstmöglichen Eintritt, zunächst im Rahmen der ANÜ

• As Senior Global Validation Manager in Global Engineering Compliance organization, you will bring in your skills in quality management systems and computerized systems validation to ensure lean implementation and continuous improvement of the HVAC/CR & Utilities validation across GFE worldwide.
• In cooperation with regional/local GFE Units, Quality and business functions, you will develop the validation and test strategy and ensure cost-efficient implementation for HVAC/CR & Utilities validation.
• You will build up and manage a team of experts across sites and functions to drive continuous improvement of validation standards, processes and capabilities to improve overall quality, compliance and efficiency.
• You will review risks regarding compliance and data integrity based on the business processes involved and propose solutions to mitigate the risks.
• You will present the validation strategy to internal customers, auditors, and regulatory authorities.
• In addition, you are the first contact for regional/local Validation Managers related to HVAC/CR & Utilities Standards across the GFE, an interface between GFE Qualification Teams and Validation Managers, IT and local/global Quality.

• Diploma or master’s degree (MBA, MSC) with major focus on engineering, sciences, Pharmaceuticals and/or Biotechnology or equivalent and longstanding professional experience in regulations and processes
• In-depth knowledge of GxP regulations, CSV&C and quality regulations/guidelines (e.g. EMA/Europe, FDA/USA, Anvisa/Brazil, CFDA/China, ICH, WHO) and in data integrity
• Deep understanding of Engineering trends and technologies with the experience how to bring and establish innovations into the business
• Project Management skills in a complex international environment of multiple projects
• Effective team player and ability to work in a rapidly changing environment
• Proficient communication skills in English (verbal and written), skills in German would be an advantage

Interessiert?

Dann senden Sie uns Ihre aussagekräftige Bewerbung mit Angabe Ihres möglichen Eintrittstermins und Ihren Gehaltsvorstellungen über das unten folgende Bewerbungsformular oder per Email an bewerbung@consult16.de oder rufen Sie uns an! Diskretion ist selbstverständlich.

Bitte geben Sie bei Email-Bewerbungen immer die Referenznummer an !

Für ein international erfolgreiches Pharmaunternehmen in Oberschwaben suchen wir zum nächstmöglichen Eintritt, zunächst im Rahmen der ANÜ

• As Senior Global Validation Manager in Global Engineering Compliance organization, you will bring in your skills in quality management systems and computerized systems validation to ensure lean implementation and continues improvement of the CSV Standards for Automation across GFE worldwide.
• In cooperation with regional/local GFE Units, Quality, IT and the Business, you will develop the validation and test strategy, ensure cost-efficient implementation and set the standards for computerized systems (e.g Automation).
• You will drive continuous improvement to CSV Standards, processes and capabilities to improve overall quality, compliance and efficiency.
• You will review the risk regarding computerized systems compliance and data integrity based on the business processes involved and propose solutions to mitigate the risks.
• You will present the validation strategy to internal customers, auditors and regulatory authorities
• In addition, you will be the first contact for regional/local Validation Managers related to CSV Standards across the GFE, an interface between local MSOs, other GFE Validation Teams and Validation Managers, GBS , IT and local/global Quality.

• Diploma or master’s degree (MBA, MSC) with major focus on IT, engineering, sciences, Pharmaceuticals and/or Biotechnology or equivalent and longstanding professional experience in regulations and processes
• In-depth knowledge of GxP regulations, CSV&C and quality regulations/guidelines (e.g. EMA/Europe, FDA/USA, Anvisa/Brazil, CFDA/China, ICH, WHO) and in data integrity
• Deep understanding of Engineering and IT trends and technologies with the experience how to bring and establish innovations into the business
• Project Management skills in a complex international environment of multiple projects
• Effective team player and ability to work in a rapidly changing environment
• Proficient communication skills in English (verbal and written), skills in German would be an advantage

Interessiert?

Dann senden Sie uns Ihre aussagekräftige Bewerbung mit Angabe Ihres möglichen Eintrittstermins und Ihren Gehaltsvorstellungen über das unten folgende Bewerbungsformular oder per Email an bewerbung@consult16.de oder rufen Sie uns an! Diskretion ist selbstverständlich.

Bitte geben Sie bei Email-Bewerbungen immer die Referenznummer an !