Quality Project Manager

Company Description

With sales of €500m and 2,800 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has built very long lasting, strong relationships with the leading global pharmaceutical companies globally by providing high quality development, industrialization and manufacturing services. Nemera develops and manufactures its own IP product platforms but also offers also fully custom developments and contract manufacturing.

Nemera’s manufacturing sites are located in the US, France, Germany, Brazil and Poland. The headquarters and Innovation Center for early device design and development are located in France (Lyon).

We have big ambitions at Nemera! We are growing our franchises and strengthening our capabilities.

Job Description

KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS:  

• Assists Associate Director of Quality in coordinating and executing goals and objectives throughout the company to improve product quality and operating system efficiency.   
• Direct and coordinate the activities of Quality Department employees.  
• Establish and maintain sound relationships with production, technology, supply chain, quality teams and cross functional personnel to identify system and compliance gaps with proposed resolutions.  
• Act as liaison with metrology, QC and compliance team
• Ensure adherence to project and company standards, while maintaining quality systems that meet customer, internal, and regulatory requirements (ISO, cGMP, FDA, Health & Safety).
• Manage claims non-conformities, investigations, problem solving, root cause analysis, champion creation of effective and sustainable corrective actions.  
• Manage process and equipment Validations for new product and existing business.
• Change control process owner
• Define and implement quality initiatives to meet KPI’s and objectives.   
• Identify opportunities for improvement through data trending and analysis, as well as develop and implement quality and inspection processes. Engage in risk assessment process; data integrity, control and management utilizing risk assessment tools such as FMEA.  
• Review and approve technical protocols, reports, and specifications, as appropriate.
• Participate and lead CAPA activities as required, utilizing problem solving techniques to reduce internal and external failures.  
• Employ necessary tools/resources and perspectives, treating all co-workers with respect/dignity and valuing feedback.    
• Responsible for the coordination and evaluation of the Quality department.   
• Supervises staff in line with company policies and laws, including hiring, training, task management, performance evaluation, discipline, and conflict resolution.
• Make hiring decisions for their direct reports.     
• Represent the Quality Department in support of customer, ISO and third-party audits.  
• Other duties as assigned  

Qualifications

POSITION REQUIREMENTS:  

• Bachelor’s degree in Engineering or related field 
• 4+ years of relevant working experience in Quality in a manufacturing environment with 1+ year experience in a supervisory role 
• Excellent communication skill with the ability to understand, read, write, and speak English 
• Ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge 
• Strong understanding of injection molding,  Automation and FMEA.
• Knowledgeable to equipment/process/product validation practices and principles.
• Excellent interpersonal, organizational and communication skills.
• Demonstrated leadership and the ability to motivate and influence others.
• Able to lift up to 30 lbs.  
• Ability to push and pull items 
• Ability to sit, stand, walk 80% of shift required 

  PREFERRED KNOWLEDGE/SKILLS: 

• Self-directed and possess knowledge of business and management principles involved in strategic planning, resource allocation and coordination of people and resources. 
• Knowledge of inspection tools, including their design, use, repair and maintenance  
• Medical device and/or Pharmaceutical Industry experience preferred  
• Six sigma training and/or certifications preferred.  
• Demonstrated organizational skills and general knowledge of PC applications such as Microsoft Word, Excel and Database software such as SAP 
• WORK ENVIRONMENT: 
• Office and clean room environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel 
• Ability to travel