Director, Quality Control

Company: Strivector
Location: Tucson
Posted on: March 18, 2023

Job Description:

BE THE CHOICE, NOT THE OPTION

Strivector specializes in catering to your specific desired company culture and purpose-filled job needs.

We help our clients meet their fast-growing business, new and existing positions with talented individuals like you.

Strivector works alongside Fortune 500, mid-sized and Start-ups for full-time and contract positions; on our list of companies, we have Bank of America, Fannie Mae, Philips, Smith & Nephew, Arthrex.

THE EMPLOYER
Take your career up a few notches with this global pioneer in pharmaceuticals and diagnostics focused on advancing science.
THE JOB
This is a Director of Quality Control position. As a Director of Quality Control your roles and responsibilities will include:

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• Leading the incoming inspection team, finished product testing team and daily technical support teams that are assigned to the Quality Control (QC) department. Providing guidance to QC team on establishing and achieving goals that meet the needs of the customer and the business.
  
• Lead with a servant leadership mentality; apply Roche Leadership Principles (Visionary, Architect, Coaching and Catalyst) as a standard way of leading direct staff towards achieving targets.
  
• Preparing the site for audit readiness (OSHA, FDA, Area audits, etc.); represent manufacturing operations during internal audits & inspections.
  
• Lead the implementation of the applicable quality compliance standards and appropriate modules for the Roche modular Quality Management System (mQMS).
  
• Manage P&L achievements, budget creation and execution, CapEx management, provides strategic decision-making, and plans for the efficient and effective use of resources within the Quality Control department.
  
• Act as a change agent and drive a culture of continuous improvement by actively demonstrating the use of Lean Manufacturing tools in everything the team does to improve efficiencies within the organization and achieving customer satisfaction.
  
• Lead the development of production quality standards, methods, policies across manufacturing operations collaborating with the development and quality assurance teams.
  
• Provide technical leadership to address non-conforming events Laboratory Exception Events, Out of Specifications, Non-Conformances & Corrective and Preventive Actions and audit findings by conducting effective root cause investigations and implementing corrective actions in a timely and compliant manner.
  
• Lead implementation of procedural controls and monitors effectiveness using data analytics.
  
• Drive the development and implementation of improved Quality Control processes through industry best practices such as Statistical Process Control.
  
• Develop, maintain and report internal KPI s to demonstrate performance of the QC function.
  
• Support direct Procurement team for critical supplier quality performance evaluations, managing standardized specifications and material acceptance criteria.
  
• Support value engineering projects for improving cost and quality.
  
• Support Operations and Development design transfer teams for development and validation of robust test methods and product release specifications for product release to the customers.
  
• Support process engineering team to optimize processes and validation of production and process control parameters.
  
• Prepare and manage budgets and resource needs, assigns projects to appropriate team members and ensures progress of the projects through completion.
  
  
  DESIRED SKILLS AND EXPERIENCE
  Most importantly, you need to be a passionate Director of Quality Control who enjoys his work and is considered to be one of the best within your organization. The ideal Director of Quality Control would be someone with deep experience in many (if not all) of the following:
  
  
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  • Bachelor s degree in life sciences or other engineering related discipline.
    
  • Master's degree or higher in Life Sciences/Engineering discipline is an asset but not required.
    
  • 10 years of progressive leadership experience in diagnostics/medical device or pharmaceutical industry, quality control, non- conformance management, process control, product transfers, requirements development and creating & implementing quality compliance processes.
    
  • Experience in a data driven decision making regulated environment
    
  • Demonstrated experience developing quality compliance processes, utilizing Lean Sigma tools, data analytics and process controls in a best-in-class manufacturing environment.
    
  • Proven track record of driving and leading change.
    
  • Strong organizational and problem-solving skills including the ability to develop and follow written procedures, document work accurately and guide others in the same.
    
  • Key attributes: Strong leadership, technical expertise preferably in Assays, data analytics, decision making, quality mindset, team player, strategic thinker.
    
  • Experience in Immunohistochemistry analytical methods is preferable.
    
  • Leadership skills to manage technical personnel - technicians, scientists.
    
  • Knowledge of department finance and project P&L.
    
    We understand that even if you are a seasoned Director of Quality Control you may not have all the skills listed here. If you are a good at what you do and have a willingness to learn, lets talk.
    
    
    ADDITIONAL INFORMATION
    Compensation: Based on Experience. One of the best in the industry
    Minimum Education: Bachelor s degree in life sciences or other engineering related discipline.
    Minimum Experience: 10 years of progressive leadership experience in diagnostics/medical device or pharmaceutical industry, quality control, non- conformance management, process control, product transfers, requirements development and creating & implementing quality compliance processes.
    Type of position: Full time Permanent Position with benefits
    Telecommute: No
    Location: Tucson, Arizona, United States
    Relocation accepted: Yes
    

Keywords: Strivector, Tucson , Director, Quality Control, Executive , Tucson, Arizona