Data Governance Specialist
This role plays a pivotal part in ensuring Regeneron's Data Governance systems and practices meet regulatory and industry compliance standards.
Responsibilities:
* Audit current and evolving regulatory guidance and industrial intelligence for IOPS business practices.
* Develop and author standards, policies, and procedures aligned with regulatory requirements and industry best practices as a Subject Matter Expert.
* Publish technical writing, research, and editing activities to ensure accuracy and consistency of documentation and obtain necessary approvals.
* Perform data mapping processes, risk assessments of GMP documentation, and criticality assessments.
* Identify potential data governance and integrity gaps and propose solutions with implementation plans.
* Lead data integrity remediation activities according to the DI Quality Plan.
* Provide expertise and support during new system and process development.
* Foster a culture of quality and Data Governance within the organisation and promote its importance across departments.
* Drove communication and collaboration between stakeholders for effective Data Governance practices.
* Encourage continuous improvement by actively seeking feedback and supporting initiatives enhancing data quality and governance.
* Lead or support initiatives embedding Data Governance principles into the company's 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, EMA Data Integrity Guide, and WHO Guide to Data Integrity.
* Technical writing experience and understanding of workflows and quality management terminology.
* Ability to collaborate with SMEs, DG Business Partners, ECM Specialists, and cross-functional teams with excellent communication skills.
* Capacity to translate complex regulatory and technical requirements into clear guidance for cross-functional teams.
* Strong stakeholder management and influencing skills.
* Experience developing global policies, procedures, and standards both with and through the business.
Education and Experience:
To be considered, candidates must hold a BA/BS degree and 7+ years of professional experience or an 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.