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Director of Outsourcing
Planet PharmaNetherlands, Netherlands12 dagen geleden
FunctieomschrijvingOversee day-to-day performance of CDMOs and clinical sites to ensure adherence to timelines, budgets, and quality standards. Monitor KPIs and implement performance improvement plans as needed. Serve as the primary point of contact for issue resolution and escalation. Collaborate with internal teams including Process Development, Quality, Regulatory, Clinical Operations, and Supply Chain. Support tech transfer, scale-up, and validation activities at CDMOs. Ensure alignment between clinical development timelines and manufacturing readiness. Ensure all outsourced activities comply with GxP, regulatory, and company standards. Proactively identify and mitigate risks related to outsourcing and vendor performance. Advanced degree in Life Sciences, Engineering, or related field (PhD, MS, or MBA preferred). 10+ years of experience in the biopharmaceutical industry, with at least 5 years in outsourcing / vendor management. Deep understanding of cell therapy manufacturing , GMP operations , and clinical trial execution . Proven track record managing CDMOs and clinical sites in a global environment. Strong negotiation, project management, and cross-functional leadership skills. Excellent communication and interpersonal abilities. Experience with autologous and / or allogeneic cell therapies. Familiarity with regulatory requirements in the US, EU, and other major markets. Experience in a fast-paced, high-growth biotech or pharma environment.
Position Summary :
We are seeking a strategic and experienced Director of Outsourcing to lead and manage external partnerships with Contract Development and Manufacturing Organizations (CDMOs) and clinical trial sites for our cutting-edge cell therapy programs . This role is critical to ensuring the timely, cost-effective, and compliant execution of manufacturing and clinical operations through external partners.
Key Responsibilities :
Strategic Outsourcing & Vendor Management
- Develop and execute outsourcing strategies for cell therapy manufacturing and clinical operations.
- Identify, evaluate, and select CDMOs and clinical sites aligned with program needs and regulatory requirements.
- Lead contract negotiations, including MSAs, SOWs, and quality agreements.
- Build and maintain strong, collaborative relationships with external partners.
Operational Oversight
Cross-Functional Leadership
Compliance & Risk Management
Qualifications :
Preferred Experience :
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Director Outsourcing • Netherlands, Netherlands