Job Description

Supply Chain Manager - North Dublin

Ref No: AM17614

County Dublin, Republic of Ireland

Competitive salary

Supply Chain Manager - North Dublin.

This position can be offered as a permanent hybrid role, typically 3 days office and 2 days work from home.

In this role you will be a senior member of the management team and will be leading and managing the Supply Chain and Logistics Department. As Supply Chain Manager you will be responsible for all supply chain (sourcing, production, distribution) oversight and responsible for distribution practices within the Quality Management System(s).
Central to this role, this position will be responsible for actively promoting and operationally optimising supply chain and distribution activities within a growing business, and will collaborate closely with other departments across the business.

Key Duties and Responsibilities
• Co-ordinate the sourcing, planning, manufacture and supply of API’s (Active Pharmaceutical Ingredients) finished products and act as Responsible Person for GDP activities.
• Manage contract manufacturers, suppliers and warehouse /logistics service providers, such that they meet the company's needs in terms of timelines, cost and quality.
• To make product available within the supply chain in a timely manner, of the appropriate quality and at most cost-effective price.
• To manage the supply chain function to ensure costs meet agreed budgets for the year.
• To manage supply chain co-ordinator workload and professional development.
• To oversee and assure quality of GDP operations, to ensure that the quality, safety and traceability of  products are maintained within the supply chain.

As Responsible Person:

• Responsible for ensuring the conditions of the Wholesale Distribution Authorisation are complied with and that the wholesale and distribution activities comply with current legislative requirements, including EU Good Pharmaceutical Distribution Practice and guidance from the HPRA.
• Ensure that the Active Substance Registration is maintained in accordance with the regulations, updated as required and renewed on an annual basis.
• Act and perform duties under the provisions of the Wholesale Distribution Authorisation
• Ensure the conditions of the WDA are maintained and provide recommendations to senior management on where the company could improve its compliance with GDP.
• Advise senior management on Good Distribution Practice (GDP), outlining where the company may not be following GDP and providing recommendations to ensure compliance with GDP.
• Ensure that operations do not compromise the quality of product by ensuring that secure systems are in place throughout the supply chain.
• Ensure that there is an adequate Quality Management System (QMS) in place and that it is maintained in compliance with GXP requirements
• Ensure Standard Operating Procedures and all master quality documents in relation to the operation of the licence are approved.
• Ensure all key personnel are trained.
• Ensure that customer complaints are dealt with efficiently and effectively as per SOP on Complaints Handling.
• Ensure that Quality Technical Agreements which impact cGDP are in place with all contractors and ensuring that suppliers and customers are approved.
• Ensure that self-inspections are performed at appropriate regular intervals following a pre-arranged programme, and necessary corrective measures are put in place.
• Decide on the final disposition of returned, rejected, recalled or falsified products


Manufacturing (via contract manufacturers):
• Co-ordinate the sourcing, planning, manufacture and supply of API’s and finished products at contract manufacturers
• Co-ordinate the approval of all artworks for new products / new customers
• Proactively identify, report, and escalate constraints within the end-to-end Supply Chain which will impact on customers
• Work closely with contract manufacturers and suppliers to ensure product is manufactured in a timely manner and in line with targets set
• Develop production plans to meet budget and forecast timelines.
• Manage inventory in accordance with agreed stocking levels and lead times. Understand and maintain the minimum necessary raw materials and finished goods inventory and report on the status of inventory levels against inventory targets.
• Develop capacity plans within respective contract manufacturers and raw material suppliers
• Maintain accurate master data e.g. lead times, batch size, safety stock target, etc. to ensure 100% data accuracy at all times.
• Set up and maintain planning model in Excel
• Provide information to contract manufacturers, internal departments and customers; ensure and maintain realistic dates on PO’s
• Maintenance of Customer Requirements Specifications
• Capacity management at contract manufacturing facilities

Distribution:
• Manage all contracted third-party Warehousing and Logistics functions
• Ensure appropriate transportation and documentation of goods in accordance with Customer Specifications
• Liaise with contract manufacturers, warehouses, logistic suppliers and customers on product distribution
• Ensure outsourced warehouses and logistics services are prepared and ready for regular inspections by the HPRA and other agencies
• Maintain accurate records
• Ensure product is manufactured in compliance with Quality & Regulatory requirements
• Liaise with and assist the quality and regulatory department with audits and inspections from time to time
• Generate and present weekly / monthly reports and metrics as appropriate
• Chair the monthly operations meeting and monthly New Product Introduction meetings
• Act as Health, Safety & Environment representative for the HSE.
• Carry out Out-Of-Stock investigations
• Own relationship/communication with the local GDP Authorities, and host External and Internal inspections in Ireland


Interested applicants should have:

• Ideally a 3rd level qualification in a business or science discipline
At least 8-10 years' experience in the pharmaceutical and/or medical device industry within a supply chain, production, distribution role. Management, supervision or leadership of a team is essential.
• Strong background in the application of GDP, ISO 13485, MDD, GMP, GVP standards.
• Ideally experience in regulatory inspections, supplier audits and customer audits.
• High level of proficiency in Microsoft Word and Excel.

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