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Qa expert

Lausanne
Inova Consulting
Inserat online seit: 2 März
Beschreibung

Job Title: Quality Compliance Expert – Audit Readiness & Data Integrity
Company: Inova )
Location: Romandy, Switzerland
Contract Type: Full-time – On-site

About Inova:
Inova is a Swiss consulting and engineering firm specializing in supporting life sciences industries through high-value expertise in quality, compliance, and digital transformation. We help our clients strengthen quality systems, enhance inspection readiness, and drive sustainable compliance across manufacturing and laboratory environments.

Position Overview:
We are seeking an experienced Quality Compliance Expert to support a major biopharmaceutical manufacturing site in Neuchâtel.
Embedded within the site Quality organization, you will play a central role in GMP self-inspection programs, inspection readiness, and data integrity governance. This position is designed for a senior QA professional who thrives in cross-functional environments and enjoys combining operational oversight with strategic quality system improvement.
You will act as a key compliance partner across manufacturing, laboratories, engineering, and warehouse operations, ensuring robust quality systems aligned with global GMP expectations and regulatory requirements.
In addition, you will contribute to continuous improvement initiatives and may act as deputy to the Head of Quality Compliance & Systems when required.

Key Responsibilities:
GMP Self-Inspection & Inspection Readiness
Define and maintain a risk-based self-inspection program
Plan and coordinate the annual self-inspection schedule with site leadership
Coach SMEs and audit teams to ensure inspection readiness
Perform gap assessments against new or revised global procedures
Ensure cross-functional coordination and effective communication
Benchmark best practices across global networks
Audit Support & Regulatory Inspections
Support preparation for internal and external GMP audits
Contribute to document review and QA oversight
Participate as backroom support or scribe during inspections
Contribute to mock audit preparation and execution
Data Integrity Governance
Act as the site Data Integrity champion
Promote strong Good Documentation Practices (GDDP)
Collaborate with global teams to ensure harmonized data integrity standards
Perform trend analysis and monitor quality metrics
Identify system gaps and implement remediation actions
Quality Systems & Continuous Improvement
Present compliance topics and quality metrics at Quality Council meetings
Support compliance-related projects and cross-functional initiatives
Contribute to risk assessments (FMEA, root cause analysis, etc.)
Provide compliance support to business partners
Act as back-up to the Head of Quality Compliance & Systems when required

Profile Requirements:
Education & Experience
University degree in a scientific or technical discipline (Biochemistry, Chemistry, Engineering, or equivalent)
Minimum 5-10 years of experience in biotechnology and/or pharmaceutical manufacturing environments
Strong expertise in GMP regulations and inspection management
Solid understanding of manufacturing, QC laboratories, and warehouse operations for biological products
Experience supporting regulatory inspections and audits
Technical & Compliance Expertise
Strong knowledge of Data Integrity principles and GDDP
Experience authoring and reviewing SOPs and technical documentation
Familiarity with electronic QMS systems (e.g., Veeva Vault, TrackWise)
Experience with risk management tools (FMEA, root cause analysis)
Ability to perform trend analysis and quality metrics reporting (Power BI is an asset)
Languages & Skills
Fluency in French and B2 in English
Strong analytical mindset with the ability to simplify complex topics
Excellent communication skills across multiple organizational levels
Autonomous, structured, and solution-oriented
Strong team spirit with coaching and influencing capabilities
Comfortable working in a matrix and international environment

Why Join Inova?
Take a strategic role in GMP compliance and inspection readiness
Act as a key driver of Data Integrity and Quality System excellence
Work at the heart of biologics manufacturing operations
Join a consulting company that values autonomy, expertise, and impact
Be part of a collaborative, high-level quality network

How to Apply:
Send your application to -
Subject line: Quality Compliance Expert

Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.

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