Posted: 30 July
Offer description
Job Opportunity: Quality Leader
We are seeking a seasoned professional to lead our quality oversight for suppliers and service providers.
* Maintain quality control and compliance for external partners and sites.
* Develop and maintain positive relationships with external stakeholders to encourage collaboration, continuous improvement, and transparency.
• Complete supplier qualification activities for existing and prospective external suppliers.
• Manage all critical quality-related issues, including deviations, complaints, and regulatory non-compliances.
• Develop and maintain quality agreements between us and external suppliers.
• Coordinate and complete audits, participating in and/or leading audits.
• Ensure change controls are managed appropriately.
• Assist in health authority inspection preparations and provide support as required.
• Track and trend key quality indicators/metrics to monitor supplier and quality management system performance.
• Assure suppliers comply with all quality management system procedures and regulatory requirements.
• Develop positive relationships with internal partners, including sites, sourcing, supply chain, etc.
• Provide quality support for new product introductions and transfers project activities.
• Interact with suppliers, sites, and sourcing to drive improvements and minimize costs of quality.
Qualifications and Requirements:
* Bachelor's degree in science discipline or equivalent knowledge/experience.
* Effective problem-solving and root-cause analytical skills to lead and influence others to drive change.
* Proficiency with Microsoft Excel spreadsheet development and analysis.
* Extensive experience conducting supplier audits in a regulated environment.
* Deep knowledge of global regulations such as GMP, FDA, ISO 9001, and other relevant standards.
* Proven success in negotiating and managing quality agreements with external partners.
REMUNERATION_MIN=100000
REMUNERATION_MAX=150000
REMUNERATION_CURRENCY=EUR
