Job Summary:
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 align with the IOPS Data Governance Program.
Key Responsibilities:
* Implement data governance standards, policies, and procedures within allocated areas of the business.
* Provide support and advice as the allocated business area's key data governance contact, engaging with the allocated business unit on data governance priorities and action plans.
* Assess the allocated business unit's current policies and processes and oversee the achievement of local data governance KPIs.
* Conduct regular data audits and assessments to identify data governance issues and work with the business area to prepare for data governance auditing and inspections.
* Collaborate with other data governance business partners, technical data governance experts, and ECM experts to deliver on the data governance plan and provide feedback to drive continuous improvement and evolution of the data governance approach.
* Foster a culture of quality and data governance within the organization and promote its importance across all departments.
* Drive communication and collaboration between stakeholders to ensure effective data governance practices.
* Encourage continuous improvement by actively seeking feedback and supporting initiatives designed to enhance data quality and governance.
* Lead or support initiatives to embed data governance principles into the company's core values and everyday practices.
Requirements:
* Knowledge of applicable federal, state, and local regulations, such as GDPR, FDA Guidance on Data Integrity, EMA Data Integrity Guide, and WHO Guide to 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 using quality systems and/or change management.
Education and Experience:
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 are required.