Job Description:
In this pivotal role, you will play a key part in shaping our site's culture of data governance (DG). This involves ensuring compliance with Data Governance policies, designing and delivering relevant training, and monitoring Data Governance practices.
The role requires fostering a culture of data stewardship, enhancing data quality, and embedding the principles of DG within our site culture.
A typical day in this role might include:
1. Collaborating with the Global DG (Policy & Programs) team to design and deliver continuous DG training aligned with current and evolving required DG knowledge, skills, and awareness needs.
This includes:
* Developing comprehensive training programs focused on DG, compliance with regulations, and best practices for bio-pharmaceutical manufacturing.
* Conducting training needs assessments to identify gaps and areas for improvement.
* Working closely with department leadership to ensure DG training aligns with operational needs and business objectives.
* Delivering DG-focused training sessions, workshops, and seminars for staff at various levels within the organization.
* Assessing the impact of industry trends and regulatory updates on training needs and program content, adjusting training strategies where necessary.
* Leveraging technology to enhance training delivery, including e-learning platforms, simulation tools, and virtual training environments.
1. Building awareness among employees of the need for and desire to build and model a mature DG culture.
2. Serving as DG advocates with Data Stewards on cultural and behavioral changes required, why they are needed, and steps that can be taken to develop an open and transparent DG culture.
3. Responsible for gathering agreed site DG KPIs and reporting their findings to the DG Business Partners for the relevant area.
4. Establishing ongoing monitoring and auditing processes to ensure DG cultural improvements are sustained.
5. Fostering a culture of quality and DG within the organization 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.
To be successful in this role, you should have:
* Demonstrated success in designing, implementing, and managing training programs for diverse audiences.
* Strong facilitation, communication, and organizational 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 organizational 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.
Required qualifications include 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.