Life Science Consultant Business System Owner BSO

We are looking for enthusiasts

KVALITO is a strategic partner and global quality and compliance services and network for regulated industries with a prime focus on life sciences. Headquartered in Basel Switzerland we have subsidiaries in Germany Czech Republic Ireland Italy Spain and Malaysia. In our clients new organization Digital and Operational Excellence we aim to drive global development and execution of technical operations. By catalyzing the power of data and digital skills we aspire to realize performance promises and deliver value to patients. Our leadership and consultants combine decades of experience in enterprise environments. To cover all essential technical areas in the field of digital and mobile KVALITO works with reliable Technology Partners worldwide. For more information please visit us at

Life Science Consultant Business System Owner (BSO)

Location: Germany

We are seeking a highly skilled and accomplished Life Science Consultant to join our team in Germany. The ideal candidate will have a proven track record of success in the life science industry specializing in Quality and GMP Compliance Computerized System Validation (CSV) and Supply Chain Management.

As a Business System Owner (BSO) for a leading pharmaceutical company you will bring a wealth of expertise in regulatory compliance project management and innovation to ensure the success of critical projects.

Major Accountabilities

1. Business System Ownership:

• Act as the BSO delegate focusing on the implementation of production planning tools within the life science industry.
• Collaborate with stakeholders to gather and analyze business requirements for computerized systems ensuring alignment with regulatory standards and industry best practices.

1. Validation Expertise:

• Develop comprehensive validation strategies including risk assessments validation plans protocols and reports to ensure system integrity and compliance.
• Implement rigorous change control processes assessing the impact of changes on computerized systems and ensuring compliance with regulatory requirements.

1. Project Management:

• Lead and manage diverse highvalue projects in the life science industry demonstrating proficiency in Lean time management and quality management systems for cGMPregulated environments.
• Enhance team control and structure through the implementation of project management tools.

1. Regulatory Compliance:

• Utilize indepth knowledge of industry regulations and standards ensuring compliance with quality and GMP requirements. Proficient in FDA and EMA guidelines.

1. Innovation and ProblemSolving:

• Demonstrate creative problemsolving skills aligning innovative solutions with rigorous regulatory frameworks including GxP requirements.
• Continually hone analytical management and communication skills.

Minimum Qualifications and Experience

Education

• Masters Degree in Sciences or Biotechnology.

Language

• Fluent in English
• Fluent in Spanish
• Fluent in Italian
• Additional European language expertise is an advantage

Work experience

• At least 5 years of practical experience as Technical lead of a pharmaceutical plant

Skills

• Knowledge of relevant industry standards & methods (ISO (ISO9001 and 14971) ICHQ GxP Qualification and Validation Quality Management QMS Process Management Lean Management Risk Management Change Management Quality and Project Management Audit)
• Basic project management good organization and planning skills
• Knowledge of CSV Quality and GMP Compliance Supply Chain Management Innovation Master Data Management IT Project Management Quality Assurance Audit Training Risk Management Change Control Plant Design Process Validation and Root Cause Analysis.
• Good analytical skills
• Effective Communication
• Demonstrates problemsolving and ideageneration skills

We offer great benefits

• Flat hierarchies and responsibility from the beginning
• Peopleoriented culture
• Diversity and inclusionfocused environment
• Global client projects in a multinational environment
• Flexible working hours and home office
• Involvement in global conferences
• Individual professional development training and coaching
• Unlimited full employment contract
• Excellent remuneration package consisting of a competitive salary plus a substantial bonus

Contact

If you have the necessary background and experience and would like to join a small team responsible for a truly global operation then please send your application to recruiting(at)kvalito.ch including your: