Artwork & Packaging Program Manager

Idorsia Pharmaceuticals Ltd; Allschwil; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Idorsia Pharmaceuticals Ltd in Basel, Switzerland, seeks a CPCTS Manager (Artwork Focus) to lead commercial artwork projects across product lifecycles within the Commercial Packaging & Clinical Trial Supply Team.

You will coordinate change management for launches, manage translations, labeling updates, and governance, collaborating with Regulatory Affairs, Marketing, QA, Supply Chain and external partners.

Qualifikationen

• University degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or another relevant scientific discipline.
• 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 strong advantage.
• Fluent in English; knowledge of another European language is considered an asset.

Aufgaben

• Lead commercial artwork projects across the product lifecycle.
• 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.

Kenntnisse

Project management

GxP knowledge

Regulatory interpretation

Stakeholder influence

Quality mindset

Leadership

English fluency

Ausbildung

Master's degree preferred

Jobbeschreibung

Idorsia Pharmaceuticals Ltd in Basel, Switzerland, seeks a CPCTS Manager (Artwork Focus) to lead commercial artwork projects across product lifecycles within the Commercial Packaging & Clinical Trial Supply Team.

You will coordinate change management for launches, manage translations, labeling updates, and governance, collaborating with Regulatory Affairs, Marketing, QA, Supply Chain and external partners.