Principal GMP Data Governance Specialist

We are currently looking to fill a Principal GMP Data Governance Specialist position. This role plays a pivotal part in ensuring that Regeneron's Data Governance systems and practices meet the highest standards of regulatory & industry compliance. The post-holder isresponsible for providing specialized knowledge and expertise in the design of Data Governance (DG) frameworks, policies & procedures that are aligned with regulatory requirements and industry standards.

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

• Assess current and evolving regulatory guidance & industrial intelligence in relation to IOPS business practices.
• Subject Matter Expert (SME) for authoring and developing the standards, policies and procedures in line with regulatory requirements and industry best practices.
• Technical writing, research, and related editing activities, ensuring accuracy and consistency of documentation and that the appropriate approvals are received.
• Generate and perform data mapping processes, risk assessments of all GMP documentation & criticality assessments.
• Identify potential data governance & integrity gaps and propose solutions with an implementation plan. Lead DI remediation activities as per the DI Quality Plan
• Provide expertise and support during the development of new systems and processes.
• Work in partnership with other Technical DG Experts, ECM Experts & DG Business Partners to deliver on the DG plan and feedback themes to allow CI & evolution of the DG approach.
• Staying updated on latest industry trends, regulatory changes and enforcement actions within the biopharma industry and assessing the impact of these within IOPS.
• Fostering a culture of quality & DG within the organization.
• Promoting the importance of DG across all departments.
• Driving communication and collaboration between stakeholders to ensure effective DG practices.
• Encouraging CI by actively seeking feedback and supporting initiatives designed to enhance data quality and governance.
• Leading/supporting initiatives to embed DG principles into the company's core values and everyday practices

This role might be for you if you:

• Knowledge of applicable federal, state, and local regulations (e.g. GDPR), rules, policies, and procedures such as FDA Guidance on Data Integrity, EMA Data Integrity Guide, and WHO Guide to Data Integrity.
• Technical writing experience and an understanding of workflows & quality management technical writing terminology.
• The ability to collaborate with other SMEs, DG Business Partners, ECM Specialists and cross-functional teams with excellent communication skills.
• Knowledge of cGMP & GDP.
• Ability to translate complex regulatory and technical requirements into clear guidance for cross-functional teams.
• Strong stakeholder management and influencing skills.

To be considered for this role you must hold a Bachelor's degree and the following amount of relevant professional experience in pharmaceutical/FDA regulated work areas such as: data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT for each level:

• Principal Specialist - 8+ years
• Staff Specialist - 10+ years

Experience of developing global policies, procedures, and standards both with and through the business preferred. Advanced degree in related field preferred. Professional qualification in Data Governance (e.g. CDMP, DGSP) preferred. Level to be determined based on qualifications relevant to the role. May substitute proven experience for education requirement.

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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.

Salary Range (annually)

$89,100.00 - $170,100.00

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