Custom Supply Specialist at Roche

Key Challenges 

• Responsible for the day to day coordination and administrative tasks around ad hoc order management, fulfillment and manufacturing including but not limited to KX unit determination, tracking of Purchase Order details, material reservation, packaging availability, vet certificates, quality memo’s and communication with Hubs and affiliates/stakeholders involved as required. 
• Operations contributor for Custom projects here specific evaluation, input and experience is needed from Operations.
• For specifically ad hoc material requests: Integrate and collect feedback from departmental Single point of contacts to ensure product flow through order management, planning, manufacturing, QC and delivery to meet the turnaround objectives and commitments. Serves as the link between planning and order management e.g material reservations and shipping requirements.
• Works closely and aligns with Production Planners, team leads and/or supervisors on any unique or special customer requests.
• Executes and ensures completion of product documentation requests for quality, regulatory and registration for Customers. Cross functional collaboration with quality, research and development and manufacturing and commercial. 
• Proactively monitor and report on ad hoc material supply status, escalate and mitigate any issues or delays, ensures alignment on new delivery expectations. 
• Draft, executes and completes Custom Product Specification (CPS) for Cat A/B - all operational sections. Packaging requirements, stability requirements, QC requirements, feasibility, labeling, CoA requirements and SMC’s. Manages review of CPS with stakeholders and updates internal shared sheets. Reviews and approves workflows. Update to procedures and relevant documentation to reflect new Customer requirements (e.g. labels).
• Involved in internal process improvements, internal/customer audits/questionnaires (if and when applicable) and the custom supply squad to prioritize meeting ever changing customer requirements.
• Accountable for (compliance related queries and investigations from Customers/Commercial) CR’s, NCR’s and other queries or inquiries from commercial and the Business team. 
• Operations Custom squad member, supporting team address custom business activities/tasks, KPI’s and goals to support custom product portfolio growth and improvements.
• Responsible for drafting, updating Custom related procedures (e.g. SOP's, WI’s) to align with best practices and continuous improvement implementation.
• Support Production Planning activities as needed or assigned.

Who you Are as an Ideal Candidate

Qualifications and Education Requirements

• Bachelor’s degree in Science (Biology, Life Sciences or similar) or Business (Logistics, Operations, Supply Chain, Project Management)
• 5+ years Pharma or Diagnostics Industry/relevant industry experience

Preferred Skills

• Demonstrated interpersonal skills to work effectively with  cross-functional, cross-enterprise, cross-cultural teams in multiple locations.
• Good communication skills.
• Understanding of Operations, Manufacturing, Logistics and Supply Chain.
• Thorough working knowledge of relevant international ISO Standards (13485, 14971) and regulations (European medical devices directives) would be advantageous.
• Advanced understanding of ERP system knowledge especially SAP (preferred).
• Foresight and ability to be innovative and find creative solutions to problems. 
• Demonstrated ability to perform multiple, fast-paced tasks
• Demonstrated ability to prioritize and perform workload effectively, with minimal supervision.
• Continuous improvement mindset.