Sr. Manager/AD, Clinical Supply Chain Management & Operational Excellence

Scorpion Therapeutics; San Francisco Caballúa; Híbrido; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A biopharmaceutical company located in Mexico is seeking a Sr. Manager for Clinical Supply Chain Management. This role leads efforts to enhance efficiency across clinical supply chains, coordinating planning, packaging, distribution, and inventory. The ideal candidate has over 5 years of experience in supply chain within the biotech industry and demonstrates strong project management skills. Experience with global logistics regulation and vendor management is essential. The position supports both clinical and commercial projects in a hybrid work setting.

Formación

• 5+ years of progressive experience in Supply Chain within the biotech/pharmaceutical industry.
• Minimum 3 years in global forwarding/trade compliance operation role for clinical/commercial products.
• In-depth understanding of project management processes like Lean/Six Sigma.

Responsabilidades

• Lead continuous improvement projects to optimize processes and foster collaboration.
• Develop and manage SOPs and processes for supply chain and international logistics.
• Ensure timely, accurate documentation for clinical supply activities.

Conocimientos

Supply Chain Management

Collaboration

Regulatory compliance

Vendor management

Process improvement

Project management

Educación

Bachelor's degree in Supply Chain, Business Administration, or Operations Management

Herramientas

Microsoft Office

ERP systems

IRT

Descripción del empleo

Role Summary

The Sr. Manager, Clinical Supply Chain Management & Operational Excellence leads continuous improvement efforts to streamline SOPs and enhance efficiency across the end-to-end clinical supply chain. This role coordinates IMP planning, forecasting, labeling, packaging, distribution, inventory monitoring, and reconciliation for assigned clinical studies, and collaborates with QA, Finance, Tax, procurement, Legal, and RA to resolve logistics issues. The position supports both clinical and commercial supply chain projects and reports to the Director, Supply Chain Management. This hybrid role requires in-person collaboration in San Francisco, CA approximately 2 days per week.

Responsibilities

• Leads continuous improvement projects to optimize processes by analyzing KPI, and fostering cross functional collaborations for improvements
• Develop and manage SOPs, work instructions, processes, systems, and forms governing supply chain management, including international logistics, in alignment with industry standards and regulatory requirements
• Support projects and process improvement efforts related to supply chain management, both clinical and commercial
• Support budget activities, including managing proposals, contracts, PO generation and invoicing approvals for clinical packaging/distribution/storage
• Strengthen oversight and tracking of Trial Master File (TMF) documents, ensuring timely, accurate, and inspection-ready documentation for all clinical supply activities
• Work with external courier and depot vendors to set up storage, Import & Export, distribution, drug return, and destruction according to the Logistics SOP/Global Standards (GDP) and related logistics procedures
• Facilitates and coordinates with parcel carriers, couriers, and logistics brokers regarding all aspects of service, including pre-conditioned shipping containers/materials, temperature data loggers, pick-up appointments, and expedited order and emergency delivery situations
• Leads and oversees the execution of temperature-controlled, on-time distribution of Eidos drug supply chain, ensuring on-time delivery and manage temperature excursions as needed
• Coordinate with external bureaus, including Customs, FDA, USDA, and/or other applicable country agencies, to resolve logistics issues in a timely manner
• Ensures the requirements and business processes associated with cross-border movements function smoothly, issues and risks are identified and managed efficiently
• Importer Of Record setup and management as applicable globally and supports import permit applications and corresponding import VAT refund as needed
• Works with internal departments including QA, Finance, Tax, procurement, Legal, and RA to resolve logistics issues, as required
• Collaborate with Clinical Operations and internal stakeholders to align on clinical demand requirements and ensure labeling and distribution plans remain adaptive to program timelines, study design changes, recruitment needs, geographic considerations, and manufacturing schedules. Act as CMC/Supply Chain SME for any potential audits
• Collaborate with QA counterparts to ensure inspection readiness and process control for all import/export and applicable clinical trial activities; may participate in regulatory inspections
• Manage and assess courier vendor’s performance and reports operational metrics (KPIs) to senior management and any regulatory reporting requirements related to import and export activities
• Assist in the process of identifying potential supply chain vendors, reviewing proposals contributing to the selection process

Qualifications

• 5+ years of progressive experience in Supply Chain within the biotech/pharmaceutical industry
• A minimum of 3 years in a global forwarding/trade compliance operation role for clinical/commercial products, including import/export experience and temperature-controlled distribution protocols
• Bachelor’s degree in Supply Chain, Business Administration, Operations Management, or similar required
• In-depth understanding of project management processes like Lean/Six Sigma
• Understands comprehensive global pharmaceutical regulatory requirements (e.g., cGMP, GDP, 21 CFR Part 11) and knowledge of relevant local pharmaceutical drug product laws and regulatory guidelines
• Strong ability to collaborate and build strategic relationships with internal and external stakeholders
• Strong understanding of import/export requirements and customs practices
• Able to independently resolve global import & export issues, especially in the USEurope
• Experience in vendor oversight and managing external partnerships and relations
• Experience in deviation investigation and CAPA implementation
• Demonstrated ability to work in a fast-paced team environment with minimal supervision and ability to multi-task across priorities
• Ability to foster a culture of continuous improvement and operational excellence and act as an influential leader without positional authority
• Proficient in Microsoft Office applications, IRT, and ERP systems preferred

Education

• Bachelor’s degree in Supply Chain, Business Administration, Operations Management, or similar required

Skills

• Proficient in Microsoft Office applications, IRT, and ERP systems