Director Sterility Assurance DPD

Company: Thermo Fisher Scientific
Location: Nashville
Posted on: March 19, 2023

Job Description:

The Sterility Assurance Director is accountable for establishing robust sterility assurance practices throughout the Drug product Division and ensuring the sterile sites within the division operate with the global sterility assurance framework. They will also be responsible to build local capabilities through coaching and mentoring of site sterility assurance staff in close coordination with the global teams.
Responsibilities:

• 
  
• 
  Define and maintain a strategy for sterility assurance throughout the division to ensure world class performance.
  
  
• 
  Develop robust Sterility Assurance programs across the sterile manufacturing sites
  
  
• 
  Act as the divisional SME for Sterility Assurance and Aseptic Manufacturing
  
  
• 
  Actively participate in and the promote the global Sterility Assurance community of practice, using the community to align and standardize aseptic practices.
  
  
• 
  Ensure alignment and adoption of best practice across the DPD network through SA policies and global SOPs.
  
  
• 
  Implement a program to mentor, coach, and develop existing site-based SA leads, and identify talent (external/internal) for importation into the program
  
  
• 
  Conduct a program of regular audits of the aseptic manufacturing processes such that processes are assessed for compliance to internal and external standards, that areas for improvement are identified in a timely manner, and real time coaching is provided to staff directly involved with and supporting aseptic manufacturing.
  
  
• 
  De-risk current aseptic practices by implementing risk identification and risk reduction programs adopting industry trends and adopting risk reducing technologies.
  
  
• 
  Provide SME support to sites undertaking business critical investigations (i.e., SA related NSEs, Adverse EM trends, media fill failures, etc.), during key audits, and during major capital projects.
  
  
• 
  Facilitate appropriate & timely handling of significant issues to senior quality management.
  
  
• 
  Advocate ThermoFisher's interests by participating with industry bodies shaping future SA guidance and influence outcome.
  
  
• 
  Partner with DPD operations and Engineering to ensure sterility assurance principles are understood and are built into operational practices and equipment design.
  
  
• 
  Partner with strategic clients to ensure DPD sterility assurance program remains as good, or better, than our clients.
  
  
• 
  Advise and lead efforts to upgrade existing facilities to meet evolving regulatory and customer expectations for aseptic filling.
  
  
• 
  Stay up to date with changing regulations and trends, actively sharing that knowledge with sites through the sterility assurance community of practice
  
  
  Internal communication
  
  • 
    
  • 
    With matrix sterility assurance organization
    
    
  • 
    With the site Quality Directors and regional quality leaders.
    
    
  • 
    With site leadership teams and key site personnel.
    
    
  • 
    Must be comfortable dealing with strong management teams and able to positively influence when necessary.
    
    
    External communication
    
    • 
      
    • Able to professionally represent the company with key industry bodies and where required clients.
      
      Minimum Requirements/Qualifications:
      
      • 
        
      • 
        Minimum BSc in Microbiology, Applied Biology, or similar.
        
        
      • 
        Substantial experience, minimum10 years' working in or directly supporting manufacturing within sterile pharmaceutical manufacturing site(s). This position requires deep understanding of sterile product manufacture and good aseptic practices. This knowledge needs to be combined with quality risk management principles.
        
        
      • 
        Thorough understanding of US and EU GMPs as it relates to sterile products.
        
        
      • 
        The role may involve frequent travel (up to 40%).
        
        
      • 
        Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
        
        
      • 
        Apply today! http://jobs.thermofisher.com
        
        
      • 
        Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
        
        
        Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Keywords: Thermo Fisher Scientific, Nashville , Director Sterility Assurance DPD, Executive , Nashville, Tennessee