Quality Manager - Single-Use Technology

Quality Manager - Single-Use Technology (100%)

Aseptconn is a leading innovator in sterile liquid technology, providing critical components, systems, and software to the pharmaceutical and biopharmaceutical industries. Our mission is to drive progress by delivering exceptional, customized solutions that enhance our customers' processes. As we expand throughout Europe, we are seeking talented professionals to join our team.

Lead and establish the quality infrastructure for our rapidly growing Single-Use Business Division, ensuring all products and processes meet stringent regulatory requirements (GMP, FDA, EU Annex
1). We are seeking a meticulous and proactive Quality Manager with deep expertise in pharmaceutical quality systems and regulatory compliance. This critical role involves building robust quality frameworks from the ground up. Based in Switzerland, you will be the guardian of quality across our entire value chain—from supplier qualification through post-delivery support. You will design and implement quality processes while collaborating with sales, product management, and solution design teams to ensure regulatory compliance without compromising business agility.

Quality System & Documentation Management

• Design, implement, and maintain QMS aligned with GMP, FDA 21 CFR Part 820, ISO 13485, and EU Annex 1
• Manage quality documentation (CoC, CoA, etc.) and regulatory submission materials
• Establish quality checkpoints, inspection protocols, and audit-ready processes
• Ensure material compliance with USP Class VI and ISO 10993 requirements

Shelf Life, Stability & Material Management

• Develop and manage shelf-life determination and stability programs
• Coordinate material compatibility studies and extractables/leachables documentation

Change Control, NCR & CAPA Management

• Lead change control processes for product modifications and process improvements
• Manage Non-Conformance Reports (NCRs) and conduct root cause analysis
• Own CAPA system from investigation through implementation and effectiveness tracking
• Lead supplier qualification, conduct audits (on-site and remote), and maintain approved supplier lists
• Evaluate supplier quality systems and manage supplier performance tracking
• Review supplier documentation for pharmaceutical compliance

Internal Audits, Inspection & Release

• Conduct audits and quality inspections at critical control points
• Support customer audits and regulatory inspections as primary liaison

• Minimum 5-7 years quality management experience in pharmaceutical, medical device, or life science industry
• Specific expertise in single-use systems or fluid path components
• Deep knowledge of GMP (EU and US), FDA regulations (21 CFR Part 820, 211), ISO 13485, and EU Annex 1
• Proven track record building or scaling quality systems in distribution or manufacturing environment
• Experience conducting supplier audits and managing supplier quality relationships
• Strong understanding of sterile manufacturing processes, cleanroom classifications, and contamination control
• Bachelor's degree in Life Sciences, Engineering, Quality Management, or related field
• Full professional proficiency in German and English (mandatory)
• Regulatory Expertise: Deep understanding of regulatory frameworks with ability to apply complex regulations
• Analytical Skills: Strong root cause analysis capabilities using structured quality tools; data-driven decision maker
• Attention to Detail: Meticulous documentation approach with zero tolerance for compliance shortcuts
• Communication Skills: Excellent presentation and stakeholder management capabilities at all organizational levels
• Collaboration: Proven ability to balance quality requirements with commercial objectives across teams
• Project Management: Strong organizational skills managing multiple quality projects simultaneously
• Proactive & Independent: Self-motivated with ability to work autonomously and escalate appropriately
• Flexibility: Willingness to travel occasionally (15-25%) for supplier audits, customer visits, and conferences

• Impact & Autonomy: Shape your own success with meaningful responsibility and freedom

Competitive Compensation:
Attractive base salary, performance bonuses, and team activities

Growth Culture:
Fast-growing market leader combining startup agility with global stability

Values-Driven:
Privately-owned Swiss company where people come first

Work-Life Balance: Flexible remote work options

Ready to Shape the Future with Us

If you are an entrepreneurial sales professional ready to make a significant impact, we would love to hear from you.

If you are interested in this position, we look forward to receiving your application!