Sr Director QA Microbiology & Lab Support

Summary: This role is responsible for the operational oversite of the QA Microbiology and Lab Support Teams at the Raheen site. This person is the leader for these two organizations and must ensure personnel management (goals, feedback, development plans, priorities, etc.) is a primary focus. This person must ensure meaningful collaboration with the global strategy leaders to ensure alignment across site. The individual in this position is also responsible for providing direction to the functional areas to ensure high-quality, safe, and effective products that are compliant with global regulatory expectations with respect to microbiological and quality control topics.

Incumbents in this position will direct the efforts of the applicable functional areas in support of compliance and business objectives and will ensure that the IOPS Microbiology and Quality Control programs remain current with industry and regulatory expectations. Individual will play a major role in the commercial operation while remaining adaptable to the changing needs of the clinical programs.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Organizational Structure and Support for QA Microbiology & Lab Support:
  
  • Define key responsibilities for QA Microbiology & Lab Support.
    
  • Manage and develop a team of individuals in alignment with Regeneron Ley Lines and QA objectives.
    
  • Ensure staff are accountable to key values and have defined goals and access to development plans.
    
  • Ability to communicate effectively and successfully manage conflict.
    

• Support Senior Global and Site Leadership Team:
  
  • Interacts with key leadership at Raheen and has the ability to effectively communicate and provide guidance on policy and solutions to issues.
    
  • Ability to interact and align with Global QA Leadership to ensure alignment across sites.
    
  • Ability to communicate gaps and hot topic lists.
    
  • Ability to present metrics, identify compliance gaps and develop continuous improvements.
    

• Inspection Readiness:
  
  • Provides support and preparation related to site inspections from regulatory agencies and partners.
    

• Support Microbiology Control Programs:
  
  • Implement Microbial and Contamination Control Strategies.
    
  • Assists in complex investigations and identification of CAPA to deter recurrence.
    
  • Knowledge of KT investigation model, Root Cause Analysis and Hazard Analysis and Critical Control Point (HACCP).
    

• Support Quality Control and Laboratories:
  
  • Implements a QC oversight function that will assist in the strengthening of performance in the QC operations including, but not limited to product transfers (from development to qualified/validated status), stability protocols and comparability protocols for assays.
    
  • Interacts with critical key QC management to identify gaps and improvement measures for the QC laboratories to ensure a successful compliance profile.
    
  • Works with key QC management to develop and oversee specifications and Key Performance Indicators.
    
  • Oversight and assistance with review of QC datasets.
    
  • Assists in complex investigations and identification of CAPA to deter recurrence.
    

Education and Experience:

A MS/BS degree in life sciences, microbiology or chemistry, medical technology, biology or related field and a minimum of 15 + years' experience in the pharmaceutical or biotechnology industry is required. Knowledge and experience in supporting biological manufacturing sites and laboratories is preferred. Experience should also include quality control, quality assurance and regulatory inspections for Biological pharmaceuticals.

#LI-Onsite #JOBSIEST #REGNIEQA
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Job Summary
Job number: R7427
Date posted : 2023-05-31
Profession: Industrial Operations and Product Supply
Employment type: Employee