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Senior Director QA

4 months ago

Tarrytown, United States Regeneron Pharmaceuticals, Inc Full time

Within this role you will be 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.

As a Senior Director QA, a typical day might include, but is not limited to, the following:

Defining key responsibilities for QA Microbiology & Lab Support

Managing and developing a team of individuals in alignment with Regeneron key Lines and QA objectives

Ensuring staff are accountable to key values and are defining goals and accessing to development plans

Communicating effectively and successfully manage conflict

Supporting Senior Global and Site Leadership Team

Interacting with key leadership at Raheen and has the ability to effectively communicate and are providing guidance on policy and solutions to issues

Interacting and aligning with Global QA Leadership to ensure alignment across sites

Communicating gaps and hot topic lists

Presenting metrics, identifying compliance gaps and developing continuous improvements

​Providing support and preparation that is related to site inspections from regulatory agencies and partners

Supporting microbiology Control Programs

Implementing Microbial and Contamination Control Strategies

Assisting 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)

Supporting Quality Control and Laboratories

Implementing 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

Interacting with critical key QC management to identify gaps and improvement measures for the QC laboratories to ensure a successful compliance profile

Working with key QC management to develop and oversee specifications and Key Performance Indicators

Oversighting and assisting with review of QC datasets

Assisting in complex investigations and identification of CAPA to deter recurrence

To be considered for this opportunity you should have 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.

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