Inspection Readiness Lead

vor 2 Monaten


Basel, Schweiz Swisslinx Vollzeit

On behalf of our client, an international healthcare company based in Switzerland, Swisslinx is looking for an Inspection Readiness Lead. This is a contract for 12 months with a high possibility of extension.

Inspection Readiness Lead will provide support during regulatory inspections and internal audits. This individual will also work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes. Additionally, the individual will work with department leaders to build an inspection readiness capability across the organization.
- Start date: as soon as possible
- Duration: 12 months
- Extension: highly possible
- Workload: 100% (mostly remote work)

Your mission:

- Lead inspection readiness activities across the Global Clinical Operations (GCO) organization and collaborate with Quality Assurance to ensure alignment across the organization
- Enhance, maintain, and update the GCO inspection readiness “game-plan” to ensure GCO operates with an always inspection ready mindset
- Lead the clinical study teams through inspection readiness preparation activities
- Establish, lead and support routine gap analysis of GCO processes and lead the efforts in preparing a strategy for correction
- Actively assist with regulatory authority inspections, including the drafting of responses pertaining to GCO
- Create and prepare monthly, quarterly, and annual status updates with regards to inspection readiness activities
- Partner with Quality Assurance and GCO teams to establish roles and responsibilities for Inspection Readiness, ensuring consistency across global inspections
- Facilitate strategic planning for GCO Inspection Readiness (site specific Inspection Plans, Roles and Responsibilities Schedule, Inspection Logistics and Training), and reporting/escalation of opportunities for process performance improvements or risk mitigation activities
- Assure effective communication tools, including structured meetings are established and maintained
- Develop effective metrics and monitoring programs to assure constant vigilance with respect to Inspection Readiness Activities
- Support developing GCO specific Inspection Readiness training program
- Conduct education programs regarding Industry and Compliance trends

Your profile:

- Education: BA or BS or 8+years with Master or above
- 10+ years of relevant experience
- Excellent communication skills
- Fluency in English



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