Global Quality Business Process Manager

Global Quality Business Process Manager

Job Description:

We are seeking a dedicated and experienced Global Quality Business Process Manager to join our team. This role is crucial in ensuring the quality management of IT system implementation projects and overseeing the lifecycle management of corporate GxP IT applications. You will act as a subject-matter expert regarding compliance with relevant regulations and will be involved in the development of design requirements, validation and testing strategies in a GxP environment. Your ability to optimize global validation approaches and present these to regulatory authorities, as well as your experience supervising cross-functional teams, will be key to your success in this position.

IT Languages:

• Python
• SQL
• Java

Key responsibilities include managing quality processes and ensuring compliance throughout application lifecycles.:

Serve as the global quality partner for IT system implementation projects and lifecycle management of corporate GxP IT applications., Act as a subject-matter expert for compliance with 21CFR Part11, GMP Annex 11, and GAMP5 within the organization., Develop design requirements and validation/testing strategies for new electronic business solutions in a GxP environment., Continuously optimize the global validation and lifecycle approach and present findings during inspections and audits., Oversee cross-functional teams for validation and qualification activities related to computerized systems., Collaborate closely with site quality and IT teams to support cost-effective electronic system solutions., Review and implement IT quality-related processes and standards., Conduct internal and external audits and manage supplier relationships for IT service providers.

Spoken Languages:

• English, German, French

Skillset:

• Project management
• Regulatory compliance
• Quality assurance
• Risk assessment
• Cross-functional team leadership

Qualifications:

• Master’s degree in IT
• Pharmaceuticals
• Engineering
• Life Sciences or a related field.
• Thorough understanding of FDA and EU guidelines
• especially in computer system validation
• quality risk management
• and data integrity.
• Extensive professional experience in quality assurance supporting IT applications in a global GxP environment
• preferably in a contract development and manufacturing organization.
• Proficiency with electronic systems such as Trackwise
• Labvantage
• SAP
• and eCTD Manager.
• Fluent in English with excellent communication skills.
• Strong interpersonal skills and a proactive
• self-motivated approach.
• Flexibility and willingness to travel occasionally.

Years of Experience:

5

Location:

Europe

Job Benefits:

• Health insurance
• Pension plan
• Flexible working hours
• Professional development opportunities
• Travel allowances

Working Conditions:

Full Time

Employment Type:

Permanent contract

Company Culture:

• We promote a culture of excellence
• collaboration
• and continuous improvement
• where every team member is encouraged to contribute their ideas and grow professionally.

Opportunities For Advancement:

• We offer numerous opportunities for career advancement and professional growth within our global network.

visa Sponsorship:

Available