Job Description
In this role, you will be responsible for implementing data governance standards, policies, and procedures into business operations.
Key Responsibilities:
1. Implement standards, policies, and procedures within allocated areas of the business.
2. Provide support and advice as the key DG contact for allocated business areas, engaging with allocated business units on DG priorities and action plans.
3. Assess allocated business units' current policies and processes, overseeing the achievement of local DG KPIs.
4. Conduct regular data audits and assessments to identify DG issues, working with business areas to prepare for DG auditing and inspections.
5. Collaborate with other DG Business Partners, Technical DG Experts, and ECM Experts to deliver the DG plan and provide feedback for continuous improvement.
6. Foster a culture of quality and DG within the organization, promoting its importance across all departments.
7. Drive communication and collaboration between stakeholders to ensure effective DG practices.
8. Encourage Continuous Improvement (CI) by actively seeking feedback and supporting initiatives to enhance data quality and governance.
9. Lead/support initiatives to embed DG 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.
To be considered for this role, you 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.