Qualification Manager

SKAN AG seeks a Qualification Manager in Allschwil to lead IQ/OQ testing and compliance for pharmaceutical isolator systems within a collaborative, flat-hierarchy team.

This position supports a dedicated Qualification Management team within the pharmaceutical sector, ensuring strict adherence to regulatory standards. The role focuses on developing test protocols, overseeing execution on complex isolator systems, and evaluating technical reports to secure approval for both internal conformity and customer-specific qualifications.

Responsibilities

• Plan and execute qualification activities for customer projects, maintenance cycles, and annual re-qualifications, ensuring compliance with GMP and MRL regulations.
• Align qualification strategies with client expectations and requirements.
• Draft detailed test protocols, including Installation Qualification (IQ) and Operational Qualification (OQ), tailored to specific projects.
• Conduct technical reviews of test reports to verify compliance and performance.
• Analyze system and process data to support quality control objectives.
• Deliver specialized training sessions, such as those focused on GMP-compliant documentation practices.
• Serve as the primary liaison between the qualification team and other internal departments.

Requirements

• A university degree or equivalent qualification in natural sciences or engineering.
• Professional experience within a GMP-regulated environment, preferably in qualification or quality management roles.
• Proficiency in MS Office applications.
• Business-level fluency in both German and English.

What the company offers

• A supportive and open corporate culture that encourages collaboration.
• Autonomy to propose and implement new ideas.
• Access to sports and social events to foster team bonding.
• Continuous professional growth through the SKAN Academy and other learning resources.
• A structured onboarding process designed to support career development.
• Flat organizational structures that enable rapid decision-making.
• Transparent communication channels across the organization.
• 25 days of annual leave, with the possibility to purchase additional vacation days.

About the company

Founded in 1968, SKAN AG is a leading provider of cleanroom equipment and isolator solutions for the pharmaceutical industry. The company values continuous internal dialogue and takes pride in delivering customer-oriented project work with enthusiasm.

• Emphasis on open communication and flat hierarchies.
• Strong focus on customer-centric project delivery.
• Encouragement of employee ideas and innovation.
• Commitment to ongoing education via the SKAN Academy.

How to apply

Documents to submit:

• diplomas
• employment references