Principal GMP Data Governance Business Partner (Data Integrity)
About this role
Within this role you will be responsible for the implementation of data governance (DG) standards, policies and procedures into business operations. You will be a site expert on Data Governance, supporting the Regeneron IOPS Data Governance and Integrity program.
In this role, a typical day might include the following:
Implementing the Data Governance standards, policies and procedures within allocated areas of the business
Being the allocated business area(s) key DG contact providing support and advice and engage with the allocated business unit on DG priorities and action plans
Assessing allocated business unit’s current policies and processes and coordinate the achievement of local KPIs
Conducting regular data audits and assessments to identify DG issues and work with business area to prepare for DG auditing and inspections
Working with DG Business Partners, Technical Experts, and ECM Experts to deliver the DG plan and provide feedback for continuous improvement
Encouraging a culture of quality and Data Governance within the organisation and promoting the importance of DG across all departments
Driving communication and collaboration between stakeholders to ensure effective DG practices
Encouraging continuous improvement by actively seeking feedback and supporting initiatives designed to improve data quality and governance
Leading/supporting initiatives to embed DG principles into the company’s core values and everyday practices
This role may be for you if:
You have knowledge of relevant regulations and guidelines (e.g., GDPR, FDA, EMA, WHO)
You have proven success in implementing and managing policies in regulated environments
You bring strong communication and collaboration skills
You are skilled in stakeholder management and influence
You have experience with quality systems and change management
To be considered for this role you must hold a BA/BS degree and 7+ years of professional experience or 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.