Quality Assurance Compliance Manager

K-Recruiting Life Sciences; Zürich; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

K-Recruiting Life Sciences in Zürich, Switzerland, seeks a Freelance QA Compliance Manager to strengthen the quality and compliance framework during a growth phase. You will own the QMS across GxP standards, lead external audits and certification activities, and support audits for customers and vendors.

You will collaborate with product, engineering and operations to embed quality into existing workflows, prepare for inspections, and drive CAPAs and risk-based improvements with strong

Qualifikationen

• 5+ years QA/Quality Compliance in regulated environments such as digital health, medtech or pharma.
• Strong knowledge of ISO 9001 and ISO 27001 standards.
• Hands-on experience with GxP systems and computerized system validation.
• Familiarity with GAMP 5 and data integrity regulations.
• Experience supporting audits, assessments and certifications.
• Excellent communication and ability to work independently across teams.

Aufgaben

• Take ownership of the quality and compliance framework across applicable standards.
• Lead external audits, surveillance activities, and certification processes from prep to closure.
• Support customer audits, quality assessments and vendor qualification activities.
• Maintain and improve quality documentation (SOPs, risk assessments, validation docs, CAPAs).
• Partner with product, engineering and operations to embed quality in workflows.
• Provide guidance and training on quality, compliance and inspection readiness.
• Identify compliance gaps and drive corrective and preventive actions.

Kenntnisse

QA Compliance

GxP experience

ISO 9001

ISO 27001

GAMP 5

Audit management

Risk management

CAPA

Data integrity

SOPs

Jobbeschreibung

Freelance QA Compliance Manager to support a growing digital health / technology organisation in strengthening and maintaining its quality and compliance framework during a period of growth and change.

Scope of Work

• Take ownership of the company's quality and compliance framework across applicable industry standards and GxP requirements
• Lead external audits, surveillance activities, and certification processes from preparation through to closure
• Support customer audits, quality assessments, and vendor qualification activities
• Maintain and continuously improve quality documentation, including SOPs, risk assessments, validation documentation, CAPAs, and related records
• Partner with product, engineering, and operational teams to integrate quality and compliance requirements into existing workflows
• Provide guidance and training to internal stakeholders on quality, compliance, and inspection readiness
• Identify compliance gaps and drive appropriate corrective and preventive actions

Requirements

• 5+ years of hands-on QA / Quality Compliance experience within digital health, medtech, pharma, or another regulated environment
• Strong knowledge of relevant quality management and information security standards such as ISO 9001 and ISO 27001
• Practical experience with GxP-regulated systems and computerized system validation
• Familiarity with GAMP 5 and applicable regulatory requirements for electronic records and data integrity
• Experience working with clinical or regulated technology environments is highly desirable
• Proven experience preparing for and managing external audits, assessments, and certification activities
• Strong understanding of risk management, CAPA, SOPs, validation, and quality systems
• Excellent communication skills and the ability to work independently across technical and non-technical teams