Director, Quality Assurance (QC Lab Oversight)

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Job description

We are currently looking to fill a Director Quality Assurance position. This position will provide professional expertise and leadership in the Quality function as it relates to Quality Control Laboratory Oversight. The individual will proactively identify and lead all aspects of implementation of industry standard methodologies for GMP across the quality control operations. Such efforts are related to assay transfers (internal and external), comparability protocols for assays, investigation assistance, trend review, specification setting, data integrity assurance practices for lab information and on the floor laboratory oversight support. There will be heavy involvement with key leaders to gain alignment for continuous improvement and relationship building. Individual will play a major role in ensuring the stability of the commercial operation while remaining adaptable to the changing needs of the clinical programs.

In this role, a typical day might include the following:

• Leading and developing a team of individuals in alignment with Regeneron and department objectives

• Development of the 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 management members to identify gaps and improvement measures for the QC laboratories to ensure a successful compliance profile

• Assisting in revising respective assay SOPs for succinctness and clarity resulting in improvement of consistency in practices and procedures, with the objective of improving robustness and compliance and reducing ambiguity

• Assisting in sophisticated investigations and identification of CAPA to deter recurrence

• Providing support and preparation related to site inspections from regulatory agencies and partners

• Partnering with critical contract laboratories to resolve compliance issues in clinical and commercial operations, collaborating with customer/partner quality organizations, and assisting with third-party contractor and supplier quality agreements

This role might be for you if you:

• Can communicate effectively and successfully handle conflict resolution

• Have prior experience in a managerial capacity within QA or QC

• Possess experience with laboratory operations, analytical transfer and validation, Pre-Approval Inspections, and product launch activities

• Exhibit a solid understanding of KT investigation model, Root Cause Analysis (RCA), Hazard Analysis and Critical Control Point (HACCP)

• Maintain current knowledge and/or experience with QA systems such as change control, investigations (laboratory), deviations, CAPA, document management systems

• Are knowledgeable in Kaizen processes, six sigma, continuous improvement

To be considered for this role you must hold a Bachelor's degree in Life Sciences with the following minimim years experience in the pharmaceutical/biotechnology industry for each level:

• Associate Director - 10 years

• Director - 12 years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.

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