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Idorsia Ltd is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Headquartered near Basel, Switzerland, Idorsia has a 25-year heritage of drug discovery, a broad portfolio of innovative drugs in the pipeline, and commercial operations in Europe and North America. The company is seeking a CPCTS Manager (Artwork Focus) to join the Commercial Packaging & Clinical Trial Supply Team in Allschwil, Switzerland.

Tasks

  • Lead and manage commercial pharmaceutical artwork projects across the product lifecycle, ensuring timely delivery, quality, compliance and alignment with business priorities.
  • Serve as the primary point of contact for artwork change management associated with product launches, regulatory submissions, market expansions and lifecycle management activities.
  • Own the artwork lifecycle from change initiation through creation, review, approval, implementation and market deployment.
  • Coordinate artwork development activities, including translations, proofreading, labeling updates and approvals, working closely with Regulatory Affairs, Marketing, Quality, Supply Chain, Manufacturing and external service providers.
  • Develop and maintain artwork project plans, timelines, risk assessments, and implementation schedules to ensure successful execution of artwork and associated packaging changes.
  • Lead cross-functional artwork governance and approval meetings, ensuring alignment across stakeholders and adherence to global and local regulatory requirements.
  • Support commercial packaging activities related to product launches, packaging updates, component changes, serialization and market-specific requirements.
  • Manage relationships with artwork agencies, packaging suppliers, and CMOs.
  • Ensure artwork and packaging components comply with regulatory requirements, serialization requirements and country-specific labeling regulations.
  • Track and communicate project status, key milestones, risks, and mitigation plans to stakeholders and leadership.
  • Coordinate all artwork-related documentation, specifications, change controls required for successful project delivery.

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.

Benefits

  • Idorsia is committed to fostering respect, fairness, and equal opportunities for all job applicants and employees.
  • The company encourages candidates with diverse backgrounds to apply and values authenticity and inclusion.
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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 Commercial Packaging & Clinical Trial Supply Team covers all disciplines from bench to bedside and collaborates with Regulatory Affairs, Marketing, Quality, Supply Chain, Manufacturing, and external service providers.

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