Director Gmp Data Governance

5 days ago

Limerick, Limerick, Ireland Regeneron Ireland Dac Full time

In this role you will act as a bridge between global policy and standard setting and the local implementation of these within the site business unit(s).
Your role will play a fundamental part in safeguarding the quality and reliability of the organisation's data which is essential for informed decision making and regulatory compliance.
In this role, a typical day might include the following: Successful building, leading and managing of the site Data Operations & Engagement, Culture & Monitoring (ECM) team Successful delivery/implementation of site data governance (DG) responsibilities and standards Responsible for successful stakeholder engagement and management across the site Responsible for establishing a successful relationship with the global Governance Team (Policies & Programs) so a clear feedback loop is established Responsible for the creation and delivery of DG training programs in consultation with Global Data Governance Senior Leadership Team Ensuring the team is appropriately resourced, supported and has the tools and direction to properly execute their function Leading cultural and people change management efforts related to DG ensuring smooth adoption of new processes, systems and ways of working within the relevant site Responsible with and through the ECM Specialists for developing and embedding DG culture across all elements of IOPS site work Responsible with and through DG Business Partners for the successful delivery of global standards, policies and procedures at site level and the monitoring of adherence to these standards Fostering a culture of quality and DG within the organisation and promoting the importance of DG across all departments Driving communication and collaboration between stakeholders to ensure effective DG practices Leading/supporting initiatives to embed DG principles into the company's core values and everyday practices This role may be for you if you have: Technical knowledge within the biotech or pharmaceutical sector, coupled with strong relationship building and analytical thinking skills Experience in implementing DG policies and initiatives within business units in a regulated environment Experience in cultural/people change management and driving cultural change related to DG 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 Strong understanding of data governance principles, regulatory requirements and industry standards and the practical application of these in business operations Extensive experience demonstrating ability to partner, influence and incorporate new standards Strong people management and team leadership experience Experience of managing and implementing training programs and monitoring KPI achievement Strong stakeholder management and influencing skills The ability to adapt in the face of changing business needs To be considered for this role you must hold a BA/BS degree and 12+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.
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We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
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.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions.
For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency.
If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process.
Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.
The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

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