Senior Manager / Team Lead Quality Systems & Process Excellence

Jobtailor; Stuttgart; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Jobtailor in Germany seeks a senior Quality Systems leader to head a global sub-team within a matrix organization. You will drive the enhancement of electronic quality management systems, own document lifecycle management, and coordinate global change controls with Quality, Regulatory Affairs and IT.

You will oversee validation activities for computerized GxP systems and review quality documents. You will develop modern GxP training concepts with international stakeholders, improve digital

Qualifikationen

• Degree in life sciences, pharmacy, or related discipline.
• Extensive quality assurance experience in regulated pharmaceutical environments.
• Experience with eQMS, eDMS, or electronic training management systems.
• Solid understanding of computerized system validation and IT oversight.
• Knowledge of change control and document lifecycle management.
• Familiarity with Data Integrity and GxP compliance expectations.
• Experience improving quality processes and driving operational excellence initiatives.
• Strong project management and stakeholder coordination skills.
• Structured, solution-oriented, and highly independent work style.
• Confident communication skills in international business environments.

Aufgaben

• Lead a small global Quality Systems sub-team within a matrix organization.
• Drive continuous improvement of electronic quality management systems.
• Own document management, training and change control processes globally.
• Coordinate global change controls with Quality, Regulatory Affairs and IT.
• Oversee validation activities for computerized GxP-relevant systems.
• Review SOPs, quality documents and procedural records.
• Develop modern GxP training concepts with international stakeholders.
• Improve digital quality processes using innovative automation approaches.
• Support inspections and audits within assigned quality system areas.
• Lead cross-functional improvement and implementation projects globally.

Kenntnisse

Quality systems

Documentation control

Regulatory affairs

IT oversight

Data Integrity

GxP compliance

Project management

Stakeholder coordination

Independent work

Communication

Ausbildung

Degree in life sciences, pharmacy, or related discipline

Tools

eQMS

eDMS

Training systems

Jobbeschreibung

Responsibilities

• Lead a small global Quality Systems sub-team within a matrix organization
• Drive continuous improvement of electronic quality management systems
• Own document management, training and change control processes globally
• Coordinate global change controls with Quality, Regulatory Affairs and IT
• Oversee validation activities for computerized GxP-relevant systems
• Review SOPs, quality documents and procedural records
• Develop modern GxP training concepts with international stakeholders
• Improve digital quality processes using innovative automation approaches
• Support inspections and audits within assigned quality system areas
• Lead cross-functional improvement and implementation projects globally

Qualifications

• Degree in life sciences, pharmacy, or a related discipline
• Extensive quality assurance experience in regulated pharmaceutical environments
• Experience with eQMS, eDMS, or electronic training management systems
• Solid understanding of computerized system validation and IT oversight
• Knowledge of change control and document lifecycle management
• Familiarity with Data Integrity and GxP compliance expectations
• Experience improving quality processes and driving operational excellence initiatives
• Strong project management and stakeholder coordination skills
• Structured, solution-oriented, and highly independent work style
• Confident communication skills in international business environments