Job Description
This opportunity offers a rare chance to make a key contribution towards building a successful ambitious young biopharmaceutical company.
Job Spec
Manager, External Supply Operations role is a highly visible position that will have primary responsibility for managing products through external manufacturing partners. Responsible for end-to-end supply chain, customer fulfilment and supporting products for both Commercial and Medical Countermeasure Business Lines. Works closely – in a matrixed and virtual environment - with Global Supply Chain, External Quality, External MSAT, Logistics, Regulatory Affairs, and Sales Operations to deliver company’s commitments and to exceed customer expectations.
• Point of contact for External Manufacturing Operations activities including: scheduling, issue resolution,
change management implementation, performance monitoring, supplier development, etc.
• Serve as a lead or supporting member on internal teams, serving as a Supply Chain representative
• Responsible for component, production, and delivery planning to ensure on-time, in-full and uninterrupted
supply
• Responsible for creating and maintaining data in SAP system in accordance with procedures, while
executing transactions to support Supply Chain operations
• Responsible for analyzing risk within the Supply Chain, developing mitigation plans, and implementing
solutions
• Maintain collaborative relationships with supporting functions to ensure complete scope of planning
activities remains connected with other business operations requirements
• Engage in performance management process to drive consistency between company and department goals
as well as personal objectives
• Support External Manufacturing by engaging with component and raw material suppliers to deliver in
support of finished goods production
External Manufacturing Operations Management:
• Responsible for monitoring external manufacturer supply/service agreements to ensure compliance
• Responsible for scheduling work at external partners in accordance with supply plans, contract
requirements, and Quality to ensure uninterrupted flow of goods and services
• Represent External Supply and present at S&OE/S&OP meetings
• Develop, monitor, and report on metrics and KPIs to drive supplier performance
• Establish jointly owned continuous improvement programs with suppliers
• Responsible for SAP inventory transactions to ensure accuracy of all purchased materials located
at external manufacturers
• Encourage implementation of industry best practices for Supply Chain activities
• Responsible for managing the coordination of deliveries while maintaining compliance with applicable
import/export laws
• Familiarity of domestic and international distribution regulations and requirements
Culture Management:
• Collaborate with support departments to build effective teams through mutual understanding of company.
goals, objectives, tools and committee structures
• Live company’s core values and operate within a culture of accountability
• Ability to effectively maintain a mindset of continuous improvement
Compliance:
• Ensure compliance with current Good Manufacturing Practices (cGMP), Sarbanes-Oxley (SOX), and other
areas of mandatory regulatory oversight
• Support through initiation, management, and completion of applicable Quality records – including
deviations, CAPA’s and change controls
• Create / revise departmental Standard Operating Procedures (SOPs)
Travel:
Approximately 5% to 10% [May include some international travel]
Person Spec
• Bachelor’s Degree: Supply Chain, Operations Management, Biochemistry, Engineering, or related field
• Minimum 5 years of relevant experience within medical device, combination drug device, biotechnology,
pharmaceutical, or contract manufacturing required
• Experience working in a cGMP environment
• Ability to work within a matrixed organization
• Hands on experience with SAP preferred
• Effective communicator with strong leadership and interpersonal skills
• Strong leadership skills with particular emphasis on relationship development and implementation of
company culture improvement initiatives
• Ability to collaborate with internal and external partners at multiple levels
• Ability to manage, prioritize and work cross functionally with team-oriented focus to influence behaviors
• ASCM or other accredited Supply Chain Certification preferred
• Must have continuous improvement mindset with strong LEAN principles and practices - Six-sigma/LEAN
certified preferred
• Experience with industry-standard software applications (MS Word, Excel, PowerPoint, Visio,) LI-Hybrid
cv to gerry@rftgroup.ie