About Us
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.
Your mission
The role is responsible for leading Supplier Quality Management and selected Quality Systems and Compliance activities across the assigned areas of responsibility. The position ensures effective qualification, oversight, and lifecycle management of suppliers, contractors, and service providers, while also supporting the maintenance and continuous improvement of the pharmaceutical quality management system. The role acts as a key contact for internal stakeholders and external partners on supplier quality, compliance, and QMS related matters and helps ensure that supplier controls and internal quality processes remain inspection-ready, risk-based, and aligned with applicable regulatory requirements and business needs.
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
Your profile
- 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.
Why us?
We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential. Here's what sets ten23 apart:- A valuable and impactful career development opportunity in an inspiring environment
- Flexible working arrangements and environment with an open culture and diverse workforce
- The opportunity to work with and learn from highly qualified and experienced employees
- Our learning and self-developing culture offers a wide range of training options
- Competitive pension fund plan, annual bonus, and other financial and non-financial benefit
At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws.
Contact
Click on Apply Now! For more information and clarification, please connect Amrith (amrith.kiran@ten23.health) from our Talent team!
