Senior Manager Data Governance

Regeneron; Ireland; On-site; EUR 70,000 - 90,000; Full time

Job summary

A leading biotechnology company in Ireland is seeking an experienced professional in Data Governance to ensure effective data management and compliance. This role involves collaboration with global teams, development of training programs, and leading cultural change initiatives. Ideal candidates will have a strong background in data governance, 8+ years of relevant experience, and a BA/BS degree. The company offers a supportive and inclusive workplace culture.

Qualifications

• 8+ years of experience in data management, quality assurance, compliance, manufacturing operations, technical operations, or IT.
• Professional qualification in Data Governance (e.g. CDMP, DGSP) preferred.

Responsibilities

• Lead site Data Operations & Engagement, Culture & Monitoring.
• Drive communication and collaboration for effective DG practices.
• Establish relationships with the global Governance Team.
• Craft and deliver DG training programs.
• Lead organisational change efforts for DG.
• Collaborate with ECM Specialists for embedding DG culture.
• Monitor adherence to global standards.

Skills

Data governance principles

Analytical thinking

Relationship building

Communication skills

Education

BA/BS degree

Job description

In this role you will act as a bridge between global policy and standard setting and the local implementation of these within their site business unit(s). You will play an integral part in safeguarding the quality and reliability of the organisation’s data which is essential for informed decision making and regulatory compliance. You will possess a blend of technical knowledge within the biotech or pharmaceutical sector, coupled with positive relationship building and analytical thinking skills.

A typical day might include, but is not limited to, the following:

• Leading & managing the site Data Operations & Engagement, Culture & Monitoring (ECM)
• Driving communication, engagement and collaboration across the site to ensure effective DG practices
• Establishing a collaborative relationship with the global Governance Team (Policies & Programs)
• Crafting & delivery of DG training programs in consultation with Global Data Governance Senior Leadership Team
• Leading cultural & people organisational change efforts related to DG ensuring smooth adoption of new processes, systems, and ways of working within the relevant site
• Partnering with the ECM Specialists for developing and embedding DG culture across all elements of IOPS site work
• Collaborating with DG Business Partners for the successful delivery of global standards, policies and procedures at site level and the monitoring of adherence to these standards
• Encouraging CI by actively seeking feedback and supporting initiatives developed to improve data quality and governance

This role may be for you if you have:

• A strong understanding of data governance principles, regulatory requirements & industry standards, and the practical application of these in business operations
• Extensive experience collaborating influencing and implementing DG policies & initiatives within business units in a regulated environment
• People management & team leadership experience
• Experience of managing and implementing training programs & supervising critical metrics
• 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 8+ years of professional experience or equivalent combination of education and experience in one of the following pharmaceutical/FDA regulated work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT.

Professional qualification in Data Governance (e.g. CDMP, DGSP) and knowledge of cGMP & GDP advantageous.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.