Ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.
We are looking for a quality leader to manage our supplier network and oversee key Quality Systems. You will handle the end-to-end lifecycle of our vendors and drive continuous improvements within our pharmaceutical QMS. As the primary contact for supplier compliance, you'll ensure our quality controls are risk-based, inspection-ready, and aligned with regulatory standards.
Your role will include,
* Direct Supplier Quality Management activities, establishing functional objectives and performance metrics to drive continuous improvement aligned with organizational goals.
* Oversee end-to-end supplier qualification and onboarding through rigorous due diligence, risk assessments, and periodic evaluations to ensure only approved partners are used for GxP activities.
* Lead supplier audits, remote assessments, and qualification visits, driving the timely resolution of audit observations and CAPAs.
* Negotiate, author, and lifecycle-manage robust Quality Agreements with suppliers, contract labs, and service providers to clearly define GMP responsibilities.
* Monitor supplier performance, quality events, change notifications, and compliance trends, ensuring immediate escalation and remediation of risks.
* Support and continuously improve core Pharmaceutical Quality Management System (QMS) processes, including deviations, CAPAs, change controls, and document management.
* Ensure all outsourced activities strictly adhere to cGMP standards, EudraLex Volume 4, ICH guidelines, and emerging industry expectations.
* Maintain constant inspection readiness by overseeing supplier controls and managing the preparation, execution, and follow-up of regulatory inspections and customer audits.
* Partner closely with Procurement, Operations, QC, Validation, and Regulatory affairs to integrate and enforce quality requirements across all business functions.
* Serve as the primary point of contact and advisor for management, internal stakeholders, and external partners on all supplier quality and compliance-related matters
We are looking for someone with:
* A Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Engineering, Chemistry, or a closely related scientific discipline.
* 7+ years of progressive experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industry, with a dedicated focus on Supplier Quality Management.
* Deep, practical knowledge of global regulatory frameworks, specifically cGMP standards, EudraLex Volume 4, ICH guidelines (particularly Q8, Q9, Q10), and FDA regulations.
* Extensive experience planning, leading, and executing external supplier audits. Lead Auditor Certification (e.g., ISO 9001, ASQ CQA) is highly desirable.
* Proven track record of managing and optimizing core QMS elements (Deviations, CAPAs, Change Controls) and authoring complex, legally binding Quality Agreements.
* Fluent in English (additional languages are a plus for global supplier interactions) and willingness to travel for on-site supplier qualification visits and audits as required.
* Onsite presence in Visp required with some flexibility to work from home
We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.
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