Principal GMP Data Governance Specialist

Within this role you will be responsible for ensuring that Regeneron’s Data Governance systems and practices adhere to the highest regulatory and industry compliance standards. They will provide specialised knowledge and expertise in designing Data Governance (DG) frameworks, policies, and procedures aligned with regulatory requirements and industry standards.

As a Principal GMP Data Governance Specialist, a typical day might include the following:

• Evaluating current and emerging regulatory guidance and industry intelligence concerning IOPS business practices

• Serving as a Subject Matter Expert (SME) in authoring and developing standards, policies, and procedures in compliance with regulatory requirements and industry best practices

• Conducting technical writing, research, and editing activities to ensure documentation accuracy and consistency, securing necessary approvals

• Generating data mapping processes and conduct risk and criticality assessments of all GMP documentation

• Identifying potential data governance and integrity gaps, propose solutions, and lead DI remediation activities per the DI Quality Plan

• Providing expertise and support in developing new systems and processes

• Collaborating with Technical DG Experts, ECM Experts, and DG Business Partners to deliver the DG plan and provide feedback to foster continuous improvement (CI) and evolution of the DG approach

• Cultivating a culture of quality and data governance within the organisation and promote its importance across all departments.

• Facilitating communication and collaboration among partners to ensure effective DG practices

• Encouraging continuous improvement by actively seeking feedback and supporting initiatives to improve data quality and governance

• Leading and supporting initiatives to integrate DG principles into the company’s core values and everyday practices

This role may be for you if:

•  You bring experience in developing global policies, procedures, and standards collaboratively with the business

• You have comprehensive knowledge of federal, state, and local regulations (e.g., GDPR), including FDA, EMA, and WHO guides on data integrity

• You have proven technical writing experience and familiarity with workflows and quality management terminology

• You bring the ability to collaborate with SMEs, DG Business Partners, ECM Specialists, and cross-functional teams, demonstrating excellent communication skills 

To be considered for this role you must hold a BA/BS degree and

• Principal GMP Data Governance Specialist : 8+ years of professional experience or equivalent in pharmaceutical/FDA-regulated environments such as data management, quality assurance, compliance, manufacturing operations, quality control, or IT.

• Staff GMP Data Governance Specialist: 10+ years of professional experience or equivalent in similar fields.

• Senior Staff GMP Data Governance Specialist: 12+ years of professional experience or equivalent in similar fields.

#IREADV #JOBSIEPR #LI-Onsite #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.