CPCTS Manager

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Idorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a 25-year heritage of drug discovery, a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, and commercial operations in Europe and North America – the ideal constellation for bringing innovative medicines to patients.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 750 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for a CPCTS Manager (Artwork Focus) to join our Commercial Packaging & Clinical Trial Supply Team !

• 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, marketexpansions 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.

• 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…