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Production Department Leader - Bulk Syringes

Ompi of America Inc
Fishers, IN Full Time
POSTED ON 12/4/2025
AVAILABLE BEFORE 2/4/2026

MISSION 

Ensures the production volumes of assigned department respecting quality standards and costs in line with the budget and industrial plan guaranteeing the highest efficiency and level of service. Coordinates and assures the employees training and development aimed to increase the quality of products and departments efficiency. Ensures by delegation HSE and corporate social accountability. 

KEY ACCOUNTABILITIES / DECISIONS AREA:

PRODUCTION MANAGEMENT 

• Ensures the effective running of production processes continuity and compliance in line with QMS, HSE, CSR, maintenance, regulatory and applicable standards, enables continuous improvement mindset, processes harmonization, in coordination with involved functions, ensuring effective cascading. 

• Executes effectively the production schedule respecting volumes, costs, time, mix, quality, managing assigned resources and workforce, systems and processes, and delivering results in line with QMS, requirements, targets, regulatory and applicable standards. 

• Executes the delivery of production plans and targets, monitoring the process, proposing improvements and executing the approved ones in order to optimize efficiency, readiness, synergies, standardization, ensuring high level of service and minimization of costs. 

• Provides the involved functions with effective and actionable technical resolutions reducing complaints increasing level of service, effectively improving quality, saturating and optimizing the capacity and the workforce, enforcing and developing capacities and technologies. 

MAINTENANCE PROGRAM EXECUTION 

• Executes the maintenance program, as well as plans and operational executions, tracks and monitors the progression during the different phases ensuring the on-time delivery, highlighting critical issues and supporting the corrective and preventive actions execution. 

• Ensures all utilities, facilities and tools are adequate, clean, subjected to maintenance and registered. 

QUALITY MANAGEMENT SYSTEM 

• Checks and approves major events and results related to quality issues, such as non-conformities, CAPAs and change controls according to Quality Management System and reviews regularly the applicable QMS documentation. 

• Contributes effectively to the QMS documentation updating in order to maintain high level of applicable standards. 

HSE MANAGEMENT EXECUTION 

• Oversees the cascading and the implementation of guidelines and procedures for the areas assigned and maintains high level of standard of HSE as evidence by safety results. 

BUDGET MANAGEMENT 

• Monitors properly the budget assigned, highlighting to the manager above eventual critical issues or specific requirements. 

MONITORING AND REPORTING 

• Monitors and reports to the manager above the production plans execution in term of time, volume, mix, quality and costs, cascading, revising and approving local ones, accordingly, working with productions leaders, in order to solve critical issues. 

PEOPLE MANAGEMENT 

• Plans, organizes, manages, coaches and develops assigned staff, ensuring the effective talent management, career path development and training, driving commitment and engagement. 

RELATIONSHIP MANAGEMENT 

• Supports the manager above in dealing with relevant external stakeholders such as customers with the aim of promoting company business, areas of expertise and competitive advantage, collects the guidance, standards and trends and transmits them to the relevant functions. 

• Interacts regularly and effectively communicates with internal and external stakeholders in order to build level of awareness on business vision and strategy, to support the processes robustness and readiness, providing feedback, evaluations on the services received from external providers and highlighting areas of improvement.


Technical Competences 

- Knowledge of product and production: process, features, techniques 

- Continuous Improvement: methodologies, techniques, principles and models 

- Lean Six Sigma and Lean Manufacturing: methodologies, techniques, principles and models 

- Legal and standard requirements and specifications such as ISO, cGMP, PDMA and guidelines 

- Knowledge of HSE Management System: process, features, techniques 

- Knowledge of Quality Management System: process, features techniques 

- IT Tools: use of company tools and applications (ERP, Office, company applications, …) 

- Analysis and Reporting: methodologies, techniques, tools and applications (such as PCS) 

- Document Management: methodologies, techniques, tools and applications 

- People Management


Education: 

Master / Engineer Degree (preferred) 

Experiences: 

3 years of experience in Pharma sector managing a large industrial department; experience in quality and/or Pharma operations is a strong plus

Salary : $80,000 - $95,000

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