Chief Risk Officer — Sterile Manufacturing Network

The mandate

A medical-device group is preparing a modular sterile-kit platform that allows hospitals to configure procedure packs from approved components. The model can reduce preparation time and waste, but the system risk is more complex than the individual items suggest. Component substitutions, packaging geometry, sterilisation load, shelf life, labelling and regional instructions can interact. Commercial teams want flexibility to address shortages and local preferences; quality and regulatory teams need assurance that each marketed configuration remains within validated boundaries.

Pilot production has exposed weaknesses in configuration governance. A permitted component change was implemented in one bill of material before its packaging and transport effect had been assessed across all kits. The issue was contained before market release, but it showed that design, supplier and commercial systems do not share one definition of an approved configuration. The board has created an independent risk seat before launch scale.

The Chief Risk Officer will provide enterprise oversight of product, supplier, sterile-barrier, regulatory, operational and continuity risk. The CRO will not own product design or release. They will establish risk appetite, aggregation and launch assurance across the complete kit system and advise the board when a bounded release, configuration restriction or pause is necessary.

The perimeter includes approximately 925 employees and material partners across Switzerland and the international network. This urgent, unplanned appointment is on site in Zurich and reports to the Chief Executive and relevant board committee. It requires direct engagement with plants, suppliers, product teams and hospitals, not risk review conducted solely through submitted documents.

Why this seat is open

Risk has been managed through quality, regulatory, operations and enterprise functions. The modular platform creates combinations and dependencies that cross those boundaries, and the pilot issue demonstrated that no independent executive owned the aggregated launch view. The board established the CRO role to provide challenge without weakening functional authority.

What you will own

• Establish the risk appetite and independent launch criteria for modular sterile kits, including patient, user, configuration, packaging, sterilisation, supplier and continuity exposure.
• Create a configuration-risk model linking approved components, substitutes, bills of material, packaging, load, shelf life, labelling, market and release status.
• Review change pathways so a component, supplier, material or commercial substitution cannot bypass system-level assessment.
• Lead risk and assurance across a broader 925-person and partner perimeter while preserving design, quality, medical and regulatory decision rights.
• Assess critical suppliers by component function, substitutability, capacity, change notification, validation and recovery rather than spend alone.
• Govern launch and disruption scenarios, including shortage-driven substitutions, packaging failure, sterilisation delay, labelling error and product withdrawal.
• Provide the board with an independent proceed, condition, restrict or pause recommendation for launch waves and major configuration expansion.
• Build enterprise risk ownership through scenario exercises and decision records rather than policy volume and generic heat maps.

The first 12 months

• Days 1–90: Reconstruct the pilot issue, identify every configuration exposed to the same control weakness and stabilise change and substitution approval. Agree launch criteria, risk appetite and board escalation. Validate the current supplier and configuration population before additional variants are created.
• Months 4–9: Implement integrated configuration risk, complete supplier and packaging assurance and run shortage and substitution exercises. Review launch markets and kit families independently, requiring conditions or exclusions where validation and traceability are incomplete.
• Months 10–12: Deliver and monitor the approved launch waves, demonstrate rapid affected-configuration identification and close pilot root causes. Extend the enterprise framework to connected sterile products and embed independent risk review into portfolio and change governance.

What the board will measure

• Every marketed kit traceable to approved components, packaging, sterilisation, label, shelf life and regional status.
• No substitution or configuration released without system-level risk and change evidence.
• Launch waves proceeding only within approved conditions, with exclusions and residual risks visible to the board.
• Critical supplier concentration and recovery actions based on patient and configuration impact.
• Successful scenario response and affected-population identification under simulated component, packaging or sterilisation failure.
• Independent risk advice changing decisions when necessary without creating duplicate operational approval.

The person

You are a Chief Risk Officer, senior quality-risk leader, product-safety executive or enterprise assurance leader with 22–28 years in medical devices, sterile products or another configuration-sensitive regulated industry. You have provided independent oversight of a complex product launch. You have influenced at least 750 employees and controlled risk, assurance or remediation exposure above CHF 200 million.

You understand how a low-risk component can create high system risk through packaging, sterilisation, labelling or use. You have governed configuration and supplier substitutions and can explain when existing validation did and did not cover a proposed change. You have made an independent launch restriction or pause recommendation.

Relevant backgrounds include procedural kits, sterile disposables, combination products, implant systems or aerospace and other configuration-controlled sectors with safety consequences. General financial-risk candidates will not fit without direct product and operating exposure.

The role is based on site in Zurich with international travel. Candidates elsewhere may qualify with relocation and European device experience. The CRO must combine independence and practicality: willing to restrict an unsupported configuration while enabling a bounded launch supported by evidence.

Compensation and terms

The indicative base range is CHF 340,000–470,000, with annual incentive and long-term participation. Measures will reflect launch assurance, configuration control, supplier resilience, scenario readiness and decision quality. This permanent role reports to the Chief Executive and board committee. Relocation and verified forfeited awards may be considered.

Confidentiality

The company, platform, pilot issue, suppliers and configurations are confidential. Identifying information will be shared only after suitability and protections are established. Applicants must not contact suppliers, hospitals or regulators to infer the client.

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