As part of PTDS Global Clinical Supply Chain Management, the Production Enablement function ensures that packaging operations can produce material required by Client's clinical trials seamlessly, on-time, and while optimizing cost/quality.
Within Production Enablement, the Global Clinical Materials Manager (GCMM) leads the coordination and execution of all procurement activities of drug products and packaging materials for global clinical studies. This includes the coordination of the release of these materials to ensure a timely production of Investigational Medical Products in accordance with international standards and regulatory requirements. Furthermore, the GCMM is responsible for all tasks related to clinical demand planning of packaging material.
Key Responsibilities
Main responsibility: Single point of contact to ensure availability of drug products and packaging materials to clinical manufacturing. This contains the following responsibilities:
Responsible for the correct master data maintenance of all drug products and packaging materials
Compile product-specific data and documents for drug products and packaging materials
Define, request and continuously update the master data of drug products and packaging materials in SAP-systems
Plan packaging materials in SAP-systems
Manage purchase orders for Client's development drug products, "Client'-Partner drug products, Client' commercial drug products and external commercial drug products from internal and external suppliers in the appropriate procurement system
Manage purchase orders for packaging materials in the appropriate procurement system
Supplier Relation Management: Manage various drug product- and packaging material suppliers to the Clinical Supply Chain Organization, incl. creating suppliers performance transparency with KPIs and taking applicable actions for continuous improvements
Support of warehouse in goods receipt questions
Perform virtual goods receipts
Responsible for ensuring batch availability of drug product and packaging materials for further manufacturing
Drive and lead the issue management for global clinical supply concerning the procurement of drug products and packaging materials as well as the goods receipt of drug product
GMP Deviation- and Change Management
Actively support inspections
Actively monitors Key Performance Indicators (KPIs) for team- and vendor-performance and works independently to develop ideas and initiates continuous improvements
Lead and participate in global / local projects to optimize Clinical Supply processes
Collaborate with Business Process Managers to exchange ideas, drive process improvement, and resolve issues on both global and local level.
Support system improvements, create and update SOPs and other department/training documents which support daily business
Job Requirements and Qualifications
Competencies
Solid understanding of the Pharma Supply Chain and clinical packaging processes
High cultural awareness and social competence required as cooperation and communication in complex situations with different cultures and countries is part of the daily job.
Well-developed teamwork, collaboration, and negotiation skills
Possess strong problem solving and decision making skills, high attention to detail, and understanding of systems and technical designs
Full use and application of basic Supply Chain/Business Process/cGMP theories, principles, and techniques
Ability to adhere to procedures and standards in a GMP environment
Ability to manage projects from initiation to delivery
Ability to work independently and set priorities. Self-motivated, proactive, quick thinking, adaptable.
Ability to communicate clearly and professionally both in writing and verbally (Excellent English skills)
Customer-focused, ability to create trustful relationships with business partners.
Ability to quickly learn a broad range of skills
Required Experience
3 years experience in the pharmaceutical, biopharmaceutical industry and/or Supply Chain Management,
Experience with SAP ERP systems
Experience with MyBuy system preferred
Education
Associate level of professional education or University degree in the pharmaceutical, biopharmaceutical or Supply Chain Management, or a Master's Degree
APICS and/or SCOR certification, or equivalent relevant experience
PMP/Operational Excellence/Six Sigma/Lean training a plus
Frequently asked questions
Who is hiring for the Global Clinical Materials Manager role?
Aequor JD is hiring for the Global Clinical Materials Manager position, a Shazamme client. Apply directly on the employer's career site.
Where is the Global Clinical Materials Manager job located?
The Global Clinical Materials Manager role with Aequor JD is based in South San Francisco, CA, US.
What does the Global Clinical Materials Manager role pay?
Aequor JD lists the Global Clinical Materials Manager role at USD 52–101 per hour.
Is the Global Clinical Materials Manager role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Global Clinical Materials Manager role?
The Global Clinical Materials Manager position is aimed at mid-level candidates.
How do I apply for the Global Clinical Materials Manager role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.