We are seeking an experienced Audit Manager to strengthen our clients Quality organisation in Switzerland. The role is responsible for planning, executing, and continuously improving internal and external audit activities across regulated manufacturing operations.
You will act as a key contributor to audit readiness, compliance assurance, and continuous improvement, working closely with cross‑functional stakeholders and supporting interactions with customers and regulatory authorities.
Key Responsibilities:
* Plan, coordinate, and execute internal audits across quality systems, manufacturing, and support functions.
* Lead and support external audits, including customer audits, certification audits, and regulatory inspections.
* Ensure timely preparation, documentation, and follow‑up of audit activities, including CAPAs and effectiveness checks.
* Maintain and continuously improve the audit management framework, processes, and documentation standards.
* Support site and global quality teams in audit readiness initiatives and inspection preparation.
* Analyse audit findings and trends to identify systemic risks and drive sustainable improvements.
* Act as a subject matter expert for audit‑related topics within the organisation.
* Train and coach internal auditors and key stakeholders on audit standards and best practices.
* Interface with customers, notified bodies, and regulatory authorities on audit related matters.
* Ensure compliance with applicable regulations, standards, and internal quality requirements.
Candidate Profile:
* Degree in a scientific, technical, or engineering discipline (e.g. life sciences, chemistry, pharmacy, engineering).
* Several years of professional experience in audit management, quality assurance, or compliance within a regulated industry.
* Strong knowledge of relevant standards and regulations (e.g. GMP, ISO 9001, ISO 13485).
* Proven experience leading internal and external audits in a manufacturing environment.
* Solid understanding of quality management systems and risk‑based approaches.
* Strong analytical, organisational, and documentation skills.
* Confident communication skills with the ability to interact professionally with internal and external stakeholders.
* Fluent in English; German is highly advantageous.
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