Senior Manager, Laboratory

Location: 

FL-Boca Raton, US

Contract Type:  Regular Full-Time
Area:  Technical Assistance
Req Id:  529978

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary:

Direct/Manage/Supervise the overall operations of a laboratory. Develop and implement strategic plans for the laboratory services, aligning with the organization's overall goals and objectives. Establish and maintain quality control and assurance programs to ensure the accuracy, reliability, and compliance of laboratory services with regulatory standards and industry best practices. Stay current with relevant regulations and accreditation requirements. Responsible for managing all operational aspects (i.e. quality systems, release, documentation, laboratory operations, compliance, training, staffing, and budgetary needs, etc.) for the Biomat RBC Processing and Specialty Testing Operations (RPSTO).

 

 

Primary Responsibilities:

  • Manages all aspects of RPSTO Operations (quality systems, test release, documentation, laboratory operations, overall compliance, oversee department budget, employee relations, etc.)
  • Ensure that laboratory operations adhere to all local, state, and federal regulations. Evaluate and implement new technologies, methodologies, and equipment to enhance laboratory efficiency and capabilities
  • Ensure compliance with cGMP and department safety practices
  • Provides guidance as well as consult with Specialty Program Management and other Biomat support departments for operational and compliance matters
  • Uses expertise and sound judgment to make independent decisions within defined areas of responsibility
  • Plans and analyzes work flow, delegates and prioritizes, to ensure that assignments and projects are completed in a timely manner and within projected budget
  • Participates in regulatory inspections and internal QA audits including providing written responses as applicable for area of responsibility
  • Practices high level of facilitation skills to reach consensus and works toward solutions
  • May review and revise Standard Operating Procedures and generate reports
  • May investigate and initiate corrective action plans for quality related issues or proactively for process improvement
  • Collaborates and efficiently communicates to internal and external customers                    
  • Applies quality risk-based processes to seek continuous improvement of systems, processes, and facilities
  • Demonstrated skills in managing projects to bring in on budget, on schedule, and technically correct
  • Provides effective leadership to employees in RPSTO                                                     
  • Is guided by and demonstrates Grifols Values

 

 

Additional Responsibilities:

In addition to the duties described above the Sr. Manager, Laboratory may also perform the following duties as assigned:

  • Quality Control (QC): 
    • Apply expertise in testing to develop, validate, and troubleshoot test methods. 
    • Serve as SME for laboratory assays and act as a resource for laboratory staff. 
    • Manage test schedules to align with Specialty Plasma objectives. 
    • Perform investigations and write reports. 
    • Author SOPs and other laboratory documents. 
    • Collaborate with Specialty Plasma, QA and other support departments on projects and incident investigations. 
    • Serve as system SME for laboratory information system and applications as required
  • Quality Compliance and Systems: 
    • Host regulatory inspections and internal QA audits. 
    • Provide compliance oversight for iRBC manufacturing and facilitate assessments against regulatory requirements: proactively assess the site's inspection readiness state.   
    • Review, and/or approve validation documents.  
    • Review and analyze data, prepare, review reports. 
    • Participate in failure (Deviation) investigations and determination of CAPAs. Author, edit, and/or approve SOPs and other documents. 
  • Quality Assurance (QA): 
    • Responsibilities may include roles (such as author, reviewer, approver) in all quality systems such as Deviations, Change Control,
    • Test result discrepancy management (including LIMS to BECS results posting) and Documentation. 
    • Manage and facilitate iRBC product release and distribution schedules. 
    • Responsible for providing direction and oversight of QA personnel (QAS).                                                          

 

 

Knowledge, Skills, and Abilities:

  • Excellent communication skills (written and verbal) and extensive working knowledge of applicable regulations (i.e. U.S. Food and Drug Administration and CLIA) and other applicable regulatory agency requirements/guidelines. 
  • Ability to perform methodical, risk-based analysis of situations and propose improvements. 
  • Good organizational skills are a must and ability to follow up on items to completion.

 

 

Education and Experience:

  • BS in a Life Sciences, Chemical Sciences, or relevant STEM degree (science, technology, engineering, math, or computer science) with minimum of 7-8 years relevant experience.
  • Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.  Example:  If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Location: NORTH AMERICA : USA : FL-Boca Raton:USBOCLA - RPSTO  

 

Learn more about Grifols

 


Nearest Major Market: Palm Beach
Nearest Secondary Market: Miami