Direkt zum Inhalt
Ein paar Leute in Laborkitteln in einem Labor

Senior Director QA (Microbiology & Lab Support)

Stellenbeschreibung

Jetzt bewerben

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.

#LI-Onsite #IREADV #JOBSIEST #REGNIEQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.