Job Summary
This role focuses on the implementation of data governance standards, policies, and procedures within business operations. The successful candidate will serve as a site resource and subject matter expert on good data governance practices, ensuring alignment with the IOPS Data Governance Program.
Key Responsibilities:
1. Implementation of standards, policies, and procedures within allocated areas of the business.
2. Act as the key data governance contact for allocated business areas, providing support and advice, and engaging with business units on data governance priorities and action plans.
3. Assess current policies and processes within allocated business units and oversee achievement of local data governance KPIs.
4. Conduct regular data audits and assessments to identify data governance issues and work with business areas to prepare for auditing and inspections.
5. Collaborate with data governance business partners, technical experts, and ECM experts to deliver on the data governance plan and provide feedback for continuous improvement.
6. Foster a culture of quality and data governance throughout the organization, promoting its importance across all departments.
7. Drive communication and collaboration among stakeholders to ensure effective data governance practices.
8. Encourage continuous improvement by actively seeking feedback and supporting initiatives to enhance data quality and governance.
9. Lead/support initiatives to embed data governance principles into the company's core values and everyday practices.
Requirements:
1. 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.
2. Demonstrated success in implementing and managing policies and standards within a regulated environment.
3. Excellent communication and collaboration skills.
4. Strong stakeholder management and influencing skills.
5. Experience in using quality systems and/or change management.
Education and Experience:
A bachelor's 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.