Data Governance Specialist
Foster a culture of data governance within the site by ensuring compliance with Data Governance policies and designing relevant training. Promote data stewardship, enhance data quality, and ensure principles are embedded in the site culture.
Key Responsibilities:
* Collaborate 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.
* Design and develop comprehensive training programs focused on DG, compliance with regulations, and best practices for bio-pharmaceutical manufacturing.
* Conduct training needs assessments to identify training gaps and areas for improvement.
* Collaborate with department leadership to ensure DG training aligns with operational needs and business objectives.
* Conduct and facilitate DG-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.
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.
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.