Quality Manager – CAPA Projects

Jobtailor; Wehrheim; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Jobtailor seeks a central Quality Management lead to advance the company-wide CAPA system, ensuring sustainable product and process quality. You will own CAPA projects end-to-end and drive timely, effective corrective actions.

You will facilitate root cause analyses, set standards and KPIs, report to management and collaborate across functions while supporting audits and SOP/Change Control improvements.

Qualifikationen

• Degree in Quality Management, a natural sciences discipline, or a related field.
• Several years of professional experience (at least 5 years) in the pharmaceutical or medical device sector.
• Solid knowledge of GMP, ISO 13485, MDR, FDA/QSR.
• Experience in project management, including complex projects.
• Strong analytical skills and a structured approach to work.
• Good written and spoken English skills.
• Confident user of SAP, MasterControl, MS Office.
• Excellent communication and moderation skills and a confident presence at management level.
• Ability to collaborate across functions and to influence stakeholders.
• Strategic thinker with a hands-on mentality, self-motivation and a strong sense of responsibility.
• Experience in change management and process optimization is an advantage.

Aufgaben

• In a central Quality Management role, you will further develop and manage the CAPA system to ensure sustainable product and process quality.
• You will own CAPA projects end-to-end, coordinate corrective and preventive actions, and ensure they are implemented on time and are effective.
• You will facilitate root cause analyses and risk assessments in a structured way and derive well-founded corrective actions.
• You will help define standards, methods and KPIs and create transparency on progress and effectiveness — including reporting to management.
• Collaboration with business units and management levels will be a regular part of your role, as will supporting audits and inspections.
• In addition, you will contribute to process improvements, for example in SOPs or Change Control.

Kenntnisse

CAPA management

Quality management

Project management

Analytical skills

English proficiency

Communication skills

Cross-functional work

Regulatory knowledge

Strategic thinking

Change management

Ausbildung

Quality management degree

Natural sciences degree

Related field degree

Tools

SAP

MasterControl

MS Office

Jobbeschreibung

Responsibilities

• In a central Quality Management role, you will further develop and manage the company‑wide CAPA system to ensure sustainable product and process quality.
• You will own CAPA projects end‑to‑end, coordinate corrective and preventive actions, and ensure they are implemented on time and are effective.
• You will facilitate root cause analyses and risk assessments in a structured way and derive well‑founded corrective actions.
• You will help define standards, methods and KPIs and create transparency on progress and effectiveness — including reporting to management.
• Collaboration with business units and management levels will be a regular part of your role, as will supporting audits and inspections.
• In addition, you will contribute to process improvements, for example in SOPs or Change Control.

Requirements

• Degree in Quality Management, a natural sciences discipline, or a related field.
• Several years of professional experience (at least 5 years) in the pharmaceutical or medical device sector.
• Solid knowledge of relevant regulations (GMP, ISO 13485, MDR, FDA/QSR).
• Experience in project management, including complex projects.
• Strong analytical skills and a structured approach to work.
• Good written and spoken English skills.
• Confident user of common systems (e.g., SAP, MasterControl, MS Office).
• Excellent communication and moderation skills and a confident presence at management level.
• Ability to collaborate across functions and to influence stakeholders.
• Strategic thinker with a hands‑on mentality, self‑motivation and a strong sense of responsibility.
• Experience in change management and process optimization is an advantage.