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As a Senior QA Compliance and Auditing Manager, you will play a key role in ensuring GMP/GDP compliance across our operations.
Tasks
- Lead and manage the supplier qualification and lifecycle management program, including qualification, periodic evaluation, requalification, and performance monitoring of GMP/GDP service providers and suppliers.
- Support the design, negotiation, implementation, and maintenance of Technical Quality Agreements (TQAs) and other quality-related contracts with external partners.
- Establish, maintain, and continuously improve supplier oversight processes using a risk-based approach.
- Lead the planning, execution, reporting, and follow-up of GMP/GDP audits of suppliers, contractors, distributors, and service providers.
- Participate in the establishment and oversight of the annual external audit program and internal self-inspection schedule based on risk assessment.
- Promptly escalate critical compliance risks and audit findings to management and ensure effective CAPA implementation.
- Manage, review, and approve change controls, deviations, CAPAs and investigations.
- Lead the development, review, and maintenance of quality procedures and compliance-related documentation.
- Manage and maintain quality documentation systems and ensure inspection readiness.
- Coordinate and support Health Authority inspections and customer audits.
- Monitor evolving GMP/GDP regulations and industry expectations and proactively implement necessary compliance improvements.
- Support the optimization of the Quality System through KPI monitoring, quality metrics, management reviews, and continuous improvement initiatives.
- Support cross-functional compliance activities and quality initiatives as needed, including Computerized Systems Validation (CSV), Data Integrity, Pharmacovigilance (GVP), Clinical Quality (GCP), and other GxP-related compliance tasks.
- Promote a strong quality culture and GxP mindset across the organization.
- Travel domestically and internationally as required to support supplier qualifications and audit activities.
Requirements
- University degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or another relevant scientific discipline (Master's degree preferred).
- Minimum 7 years of experience in pharmaceutical Quality Assurance, Compliance, Supplier Quality, Manufacturing Quality, or related GxP functions.
- Demonstrated experience managing supplier qualification programs and conducting GMP/GDP audits as Lead Auditor.
- Strong knowledge of pharmaceutical development, manufacturing, packaging, testing, storage, and distribution activities.
- Excellent knowledge of relevant GMP/GDP regulations and international quality standards, including EU GMP, EU GDP, ICH, PIC/S, WHO, FDA, and ISO requirements.
- Proven ability to independently interpret regulations and implement pragmatic, risk-based compliance solutions.
- Experience in developing and managing Quality Agreements and external partner oversight programs.
- Strong project management skills with the ability to manage multiple priorities in a dynamic environment.
- Excellent analytical, organizational, and problem-solving capabilities.
- Confident, proactive, and capable of influencing stakeholders at all organizational levels.
- Strong interpersonal, communication, and leadership skills.
- Knowledge of other GxP areas such as Pharmacovigilance (GVP), Clinical Quality (GCP), Computerized Systems Validation (CSV), or Data Integrity requirements would be a strong advantage.
- Fluent in English; knowledge of another European language is considered an asset.
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Über uns
Idorsia Pharmaceuticals Ltd ist ein biopharmazeutisches Unternehmen mit Sitz in Allschwil. Das Unternehmen erforscht, entwickelt und vermarktet innovative Medikamente für Patientinnen und Patienten mit hohem medizinischem Bedarf. Idorsia konzentriert sich auf eigene Wirkstoffforschung, klinische Entwicklung und Kommerzialisierung ausgewählter Therapien. Die Forschungs- und Entwicklungsaktivitäten bauen auf langjähriger Erfahrung in der pharmazeutischen Wirkstoffentwicklung auf.
Das Team
The Compliance & Auditing Team covers all disciplines from bench to bedside within Technical Operations - Global Quality Management.