Job Title:
Data Governance Specialist
About the Role:
Foster a culture of data governance within the site by ensuring compliance with Data Governance policies; designing and delivering relevant training; and monitoring Data Governance practices.
Key Responsibilities:
* Design and deliver continuous Data Governance Training in line with current and evolving required Data Governance knowledge, skills and awareness needs.
* Design comprehensive training programs focused on Data Governance, compliance with regulations, and best practices for bio-pharmaceutical manufacturing.
* Collaborate with department leadership to ensure Data Governance training aligns with operational needs and business objectives.
* Conduct and facilitate Data Governance focused training sessions, workshops, and seminars for staff at various levels within the organisation.
* Assess the impact of industry trends and regulatory updates on training needs and program content and adjust training strategies where necessary.
* Leverage technology to enhance training delivery, including e-learning platforms, simulation tools, and virtual training environments.
Culture and Behavioural Change:
* Build awareness through engagement with employees of the need for and the desire to build and role model a mature Data Governance culture.
* Act as Data Governance advocates with Data Stewards on the culture and behavioural changes required, why, and steps that can be taken to develop an open and transparent Data Governance culture.
* Responsible for gathering agreed site Data Governance KPIs, reporting their findings to the Data Governance Business Partners for the relevant area.
* Establish ongoing monitoring and auditing processes to ensure Data Governance cultural improvements are sustained.
* Fostering a culture of quality and Data Governance within the organisation and promoting the importance of Data Governance across all departments.
* Driving communication and collaboration between stakeholders to ensure effective Data Governance practices.
* Leading/supporting initiatives to embed Data Governance principles into the company's core values and everyday practices.
Requirements:
* Demonstrated success in designing, implementing, and managing training programs for diverse audiences.
* Strong facilitation, communication, and organisational skills.
* Experience with training management systems and e-learning tools (e.g., LMS, Articulate).
* Strong analytical skills and attention to detail.
* Strong stakeholder management and influencing skills.
* Experience in cultural/people change management and organisational development.
* 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.
Education and Experience:
Bachelor's degree and 5+ 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.