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3 days left principal data integrity lead

Ennis
Regeneron Pharmaceuticals, Inc
Principal
Posted: 8 May
Offer description

Data Governance Program Lead

This role involves implementing data governance standards, policies, and procedures into business operations.

As a site resource and subject matter expert on good data governance practices, you will ensure Business Groups are aligned with the IOPS Data Governance Program.

* Implement standards, policies, and procedures within allocated areas of the business
* Support and advise allocated business area(s) as key data governance contact
* Assess current policies and processes, oversee achievement of local data governance KPIs
* Conduct regular data audits and assessments to identify data governance issues
* Work with business area to prepare for data governance auditing and inspections
* Foster a culture of quality and data governance within the organization
* Drive communication and collaboration between stakeholders to ensure effective data governance practices
* Encourage continuous improvement by seeking feedback and supporting initiatives
* Lead/support initiatives to embed data governance principles into core values and everyday practices

Requirements:

* Knowledge of federal, state, and local regulations (e.g. GDPR), rules, policies, and procedures such as FDA Guidance on Data Integrity
* Demonstrated success in implementing and managing policies and standards within a regulated environment
* Excellent communication and collaboration skills
* Strong stakeholder management and influencing skills
* Experience in use of quality systems and/or change management

Qualifications:

* BA/BS degree or equivalent combination of education and experience in pharmaceutical/FDA regulated work areas
* 7+ years of professional experience in data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT

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