Our client is a global leader in the biotech sector who are investing heavily in their Irish presence. This involves the construction of a new state-of-the-art biologics drug substance manufacturing facility in Munster. They are currently hiring an experienced Site QA Data Compliance Lead (AD) to join their operation.
As Site QA Data Compliance Lead (AD) you will be responsible for ensuring the management, accuracy, quality, and security of data. This position is responsible for implementing data management and governance practices whilst ensuring compliance. The Site Data Compliance Lead will collaborate with the Global Team and local cross functional teams across all levels of the organisation to develop and maintain data standards, policies, and procedures.
Other key responsibilities would include:
- Develop and implement data governance strategies and frameworks to ensure data quality, consistency, and integrity. Ensure completion and maintenance of data flow maps, as applicable, to identify data integrity risks and define mitigation strategies.
- Serve as a global data management SME to facilitate and drive improvements in M&Q data-related corporate quality standards, business processes, organisational design, and governance necessary for ongoing data integrity effectiveness.
- Conduct regular data quality audits of current-state procedures and system functionality, including but not limited to, physical and logical security, electronic records/electronic signatures (ER/ES), audit trails, data mapping, records/data backup, archive and retention, computer system validation, infrastructure qualification, investigation, and training programmes.
- Serve as the Site Liaison with the Global Data Management organisation forming the data community of practice; provide feedback to the site for opportunities or concerns.
- Provide training to staff on quality-related procedures and best practices, including data management training programmes for employees.
- BSc. in IT, Computer Science, Engineering, QP or equivalent QMS Qualifications.
- 8 years' GMP experience (3 of which leading a site data management and/or data integrity programmes).
- Strong understanding and working knowledge of local and international data integrity regulations, data quality management, data security and other policies/regulations as applicable.
- Ideal candidate will be a self-starter, with strong interpersonal skills and be a strong decision-maker. This is an individual contributor position, which can grow into a more senior / people management role.
To discover more about this opportunity, apply now or contact Déanna Healy at HRM Search Partners on +353 87 6369263 for a confidential discussion.