Senior GMP Data Governance & Engagement Specialist

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Job description

The Data Governance (DG) ECM champions a culture of data governance within their site by ensuring compliance with DG policies; crafting and delivering relevant training; and monitoring DG practices. The role is pivotal in promoting data stewardship, improving data quality and ensuring DG principles are embedded in the site culture.

As a Senior GMP Data Governance & Engagement Specialist, a typical day might include the following:

• Working in conjunction with the Global DG (Policy & Programs) Team to craft & deliver continuous DG Training in line with current and evolving required DG knowledge, skills and awareness needs. This includes:
• Crafting, developing & delivery of comprehensive training programs focused on DG, compliance with regulations, and standard methodologies for bio-pharmaceutical manufacturing while using e-learning platforms, simulation tools, and virtual training environments
• Assess industry trends and regulatory updates on training needs and program content and adjust training strategies
• Support the business to embed DG into recruitment, induction & people development processes
• Act as DG advocates with Data Stewards on the culture & behavioural changes required, why, and steps that can be taken to develop an open & visible DG culture
• Responsible for capturing agreed site DG metrics, reporting their findings to the DG Business Partners for the relevant area
• Establish ongoing monitoring and auditing processes to ensure DG cultural improvements are sustained
• Work in partnership with other ECM Experts, Technical DG Experts & Business Partners to deliver on the DG plan and feedback themes to allow CI & evolution of the DG approach

This role may be for you if you enjoy:

• Staying updated on the 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 organisation and promoting the importance of DG a
• 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 companys core values and everyday practices

In order to be considered for this position, you must hold a BA/BS degree and 5+ years of professional experience or equivalent combination of education and experience in pharmaceutical/FDA regulated work areas such as: data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT. Experience in cultural/people change management and organizational development and 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. Knowledge of cGMP & GDP.

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)

$59,700.00 - $126,800.00

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