The Vice President of Operations will strategically plan, organize, direct, manage and develop integrated processes to manage product selection and utilization and will head the Operations team at Company. This person will manage oversight and governance of all vendors to develop and/or improve appropriate external resourcing strategies. This is an exciting time to join Company as our technology is entering commercialization.
- Hands-on strategic leadership of supply chain management, manufacturing, negotiation, strategic planning and forecasting, cost reduction, quality control and stable supply chain for on time delivery of various products to customers.
- Lead the process of supplier management, including managing relationships with key/critical suppliers (product roadmaps, business reviews, scorecards in collaboration with CM’s, keep supply base engaged, and driving cost reductions through supply chain
- Lead the process of supporting manufacturing, including sourcing critical materials and assemblies in coordination with R&D, suppliers and contract manufacturers (CM), and working with CM’s (instrument and reagent) to drive production cost down.
- Make recommendations, and drive programs to improve purchased material and supplier performance
- Lead team responsible for day to day operational oversight of outsourcing, vendor performance and delivery including but not limited to due diligence, RFIs/RFPs, supplier bid analysis, technical, financial, and quality due diligence, preparation of materials for team recommendation to appropriate governance bodies, contract award/decline, and supplier relationship management.
- Develop, implement and maintain risk assessment tools to evaluate vendor risk profiles and establish remediation strategies/plans to improve supply chain robustness.
- Monitor supplier performance to assess ability to meet quality and delivery requirements.
- Successful onboarding and management of new vendors.
- Define the operating approach to transition new products from R&D to production. Setup and manage pilot scale instrument and reagent production in-house prior to transferring products to contract manufacturers. Develop and manage the transfer of products between Company and contract manufacturers.
- Develop and evolve a vision for an outsourced manufacturing operation for the group and exercise good judgment in balancing:
- Outstanding product technical performance.
- High quality and reliable products.
- Dependable supply chain that allows uninterrupted development of the business.
- Robust inventory management strategies.
- Low cost of goods.
- Partner with Development teams to design products for manufacturability, develop process validation plans, and create process instructions and methods for all products and subassemblies
- Lead the process to track in-process manufacturing performance including batch records, in-process component failures and analysis
Quality Assurance & Facilities
- Own the Omnify PLM system and documentation control processes
- Develop the Quality Management System
- Lead the international regulatory compliance for our products, corrective and preventive action (CAPA) process
- Manage facilities, including and not limited to: employee health & safety, security, building management etc.
Experience And Capabilities
- 20 + years of experience with working knowledge of regulated medical device or life science industries. Proven experience and preferably leadership in vendor management, knowledge and experience of vendor selection methods.
- Proven ability to lead and develop people, and ability to lead and influence in a matrix organization. Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities
- Flexibility to attend early meeting or late meetings due to time zone differences, and travel upto 20% of the time, including international travel.
- Exceptional negotiation, interpersonal and communication skills. Strong track record of negotiation skills with value outcomes
- Strong understanding of supply chain cost and accounting principles is a must
- Ability to operate in fast-paced environment
- Analytical mindset, fact-based decision maker