Join to apply for the Senior Manager Data Governance role at Regeneron.
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.
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