Instrumentation Laboratory Company

Director of Operations & Site Leader, Transfusion, Warren

Instrumentation Laboratory Company • $125K — $150K *
Warren, NJ 07059In-Person
Healthcare
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Science required; Master's preferred.
  • 8+ years in Operations and Supply Chain leadership in a regulated environment.
  • Lean Training and/or Six Sigma Certification essential.
  • Knowledge of FDA regulations and Good Manufacturing Practices (GMPs) required.
  • Experience in Aseptic Manufacturing and both automation and manual operations.

Responsibilities

  • Direct and lead manufacturing and supply chain departments for quality and efficiency.
  • Ensure that Quality, Compliance, and Safety are embedded in all operations.
  • Oversee strategic planning and site communication while engaging stakeholders.
  • Build a self-sufficient, high-performing team through mentorship and coaching.
  • Manage supply chain processes for seamless operations and supplier sourcing.
  • Maintain financial oversight, ensuring budget adherence and expense management.
  • Foster collaboration across departments to drive process improvements.

Benefits

  • Comprehensive health and wellness programs.
  • Opportunity for professional development and training.
  • Collaborative and engaging workplace culture.
  • Financial oversight responsibilities that enhance strategic decision-making.
  • Potential for international travel for networking and collaboration.
Full Job Description
Overview

Job Summary

Responsible for manufacturing and supply chain operations and site leadership activities for the Warren, New Jersey Transfusion location. The Director of Operations directs and coordinates a diverse manufacturing and supply chain operation consistent with company schedules, budgets, goals and strategic objectives. This role ensures quality standards, productivity, and overall efficiency of area maintained and/or improved. As Site Leader, this position plays a critical role in fostering a culture of collaboration and continuous improvement, mentoring and developing a diverse team of professionals, acting as the primary point of contact for the site, and managing the overall site budget. This position reports to the VP Operations, Transfusion.

Responsibilities

Key Accountabilities
  • Directs and provides leadership for Warren manufacturing (MFG) and supply chain (SC) departments, ensuring high quality products, consistent and reliable supply and delivery, as well as cost efficient operations.
  • Lead from an expectation that ensures Quality, Compliance, and Safety are core values. They must be givens in every aspect of operations from meeting production requirements to delivery of products as well as maintaining the facility. Ensure operation runs consistently within compliance of regulatory requirements (FDA, Health Canada, IVDR, GMP, etc) and defined company SOPs.
  • Provide site leadership in operational management, strategic planning, compliance and quality assurance, site and stake holder communication, site culture and engagement, adoption of new systems, and financial commitments.
  • Build and develop a team that is self-sufficient in executing the mission of the team in support of operations and one that develops future operational and technical bench strength. Mentor, coach and build high performance talent. Identify and select colleagues who have the right skill set and commitment to meeting elevated standards and our quality requirements.
  • Implement and monitor safety programs, hazard assessments, and emergency response plans to protect employees and maintain compliance with occupational health and safety regulations.
  • Lead and manage supply chain to ensure continuity of supply. Develop and execute global strategic supplier sourcing, tactical purchasing, and materials coordination to meet sales and distribution demand for finished. Strategic responsibility for purchasing functions, warehousing operations, Supply/ Demand Planning, and Master Production Scheduling.
  • Ensure continuity of supply is maintained by managing end to end operations, including prompt resolution of any product or production related issues.
  • Financial Oversight of the full site: Manage budgets, monitor expenses, and ensure financial targets are met.
  • Drive a culture of quality, including ensuring the following are completed in a timely and effective manner: provide appropriate Subject Matter Expertise Support as necessary to support or lead investigations and actions tied to TrackWise (including ICAR's, Deviations, OOS's and Complaint investigations; completing all CAPA related and compliance support activities with fundamentally sound and robust actions; maintaining euipment and facilities to meet or exceed GMP requirements and ensure a clean, well organized and a safe environment.
  • Establish strong working partnerships based on a commitment to teamwork and mutual accountability to ensure alignment on project priorities and goals. Must be able to work closely and communicate with other departments.
  • Coordinate with other functions (Accounting; Quality; Marketing and R&D) to identify cost of goods drivers and identify process improvement projects linked to driving improvements in cost of goods.
  • Must be able to interface with regulatory agencies for site audits.
  • Performs other duties and responsibilities as assigned
  • Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.


Networking/Key Relationships:
  • Employees at all levels of the organization - Foster a culture of collaboration, engagement, and safety awareness across all teams.
  • External Regulatory Bodies - Maintain strong relationships and compliance with TUV, FDA, and other agencies; ensure readiness for audits and inspections.
  • Vendors - Partner for audits and vendor assessments to ensure quality, reliability, and adherence to safety and compliance standards.
  • Client Services - Collaborate to ensure successful delivery of products to customers and address any supply chain challenges proactively.
  • Marketing - Align on forecasts and communicate any potential supply or safety-related disruptions.
  • This position will network across all functional areas and levels within the organization as well as develop and maintain key relationships with the senior management team throughout Werfen Transfusion leadership team


Qualifications

Minimum Knowledge & Experience required for the position:
  • Bachelors of Science degree required.
  • Master's degree preferred.
  • Minimum of 8 years leading in Operations and Supply chain in a regulated and diagnostics environment required.
  • Lean Training and/or Six Sigma Certification
  • Experience in FDA regulated industries and knowledge of GMPs
  • Experience building high performing teams and driving continuous improvement
  • Experience in Aseptic Manufacturing
  • Experience in automation and manual operations

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:
  • Strong verbal and written communication skills, strong negotiation acumen
  • Team development
  • Works well with diverse groups of people, strong interpersonal skills
  • High level of autonomy
  • Working knowledge of Microsoft Office; extensive experience with large enterprise resource planning (ERP) system (SAP).

Travel requirements:
  • Up to 10% of time, to include international travel

About Instrumentation Laboratory Company

Instrumentation Laboratory Company (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, with a focus on Critical Care and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. IL develops, manufactures and distributes diagnostic solutions including: critical care systems, hemostasis systems and information management systems. IL's products are used in hospitals around the world, including large hospital systems, independent hospitals and clinics, and reference laboratories. IL is headquartered in Bedford, Massachusetts, and has operations in Europe, the Middle East, Africa, Asia-Pacific, and Latin America.
Learn more about Instrumentation Laboratory Company
Size
1,000 employees
Industry
Healthcare
Net Income
$50 million
5 Year Trend
+5%
Revenue
$500 million
* Ladders Estimates

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