[15h Left] Sr GMP Data Governance

In this role you will be responsible for fostering a culture of data governance (DG) within the site by ensuring compliance with Data Governance policies; designing and delivering relevant training; and monitoring Data Governance practices. The role is pivotal in promoting data stewardship, enhancing data quality and ensuring the principles are embedded in the site culture.

In this role, a typical day might include the following:

1. Working in conjunction with the Global DG (Policy & Programs) team to design and deliver continuous DG Training in line with current and evolving required DG knowledge, skills and awareness needs. This includes:

1. Designing and developing comprehensive training programs focused on DG, compliance with regulations, and best practices for bio-pharmaceutical manufacturing.
2. Conduct training needs assessments to identify training gaps and areas for improvement.
3. Collaborate with department leadership to ensure DG training aligns with operational needs and business objectives.
4. Conduct and facilitate DG focused training sessions, workshops, and seminars for staff at various levels within the organisation.
5. Assess the impact of industry trends and regulatory updates on training needs and program content and adjust training strategies where necessary.
6. Leverage technology to enhance training delivery, including e-learning platforms, simulation tools, and virtual training environments.

1. Build awareness through engagement with employees of the need for and the desire to build and role model a mature DG culture.
2. Act as DG advocates with Data Stewards on the culture and behavioural changes required, why, and steps that can be taken to develop an open and transparent DG culture.
3. Responsible for gathering agreed site DG KPIs, reporting their findings to the DG Business Partners for the relevant area.
4. Establish ongoing monitoring and auditing processes to ensure DG cultural improvements are sustained.
5. Fostering a culture of quality and DG within the organisation and promoting the importance of DG across all departments.
6. Driving communication and collaboration between stakeholders to ensure effective DG practices.
7. 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:

1. Demonstrated success in designing, implementing, and managing training programs for diverse audiences.
2. Strong facilitation, communication, and organisational skills.
3. Experience with training management systems and e-learning tools (e.g., LMS, Articulate).
4. Strong analytical skills and attention to detail.
5. Strong stakeholder management and influencing skills.
6. Experience in cultural/people change management and organisational development.
7. 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.

To be considered for this role you must hold a BA/BS 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.

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