CPCTS Manager

Job description

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 ! Job Responsibilities 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. Candidate’s 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. Work Location: Allschwil, Switzerland Business Area: Technical Operations - Global Supply Chain - Commercial Packaging & Clinical Trial Supply Job Type: Permanent, full time Job ID : 4808 At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success. We encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability to submit their job applications. All applicants will receive consideration. We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees. Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course. Idorsia Pharmaceuticals Ltd ("Idorsia") is committed to a fair and transparent application process. In order to avoid any conflict of interest in line with Idorsia Code of Business Conduct, which would undermine such a commitment, the applicants must disclose any personal, financial, or other outside interests interfering with the interests of Idorsia. Further, the applicant is obliged to disclose any and all relationships with close or affiliated persons, who are employees of Idorsia or are collaborating with Idorsia in any other contractual relationship. Please note Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates, or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.