Senior QA Data Integrity Specialist

1 week ago

Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

In this role you will be responsible for fostering a culture of data governance (DG) within the site by ensuring compliance with Data Governance policies; designing and delivering relevant training; and monitoring Data Governance practices. The role is pivotal in promoting data stewardship, enhancing data quality and ensuring the principles are embedded in the site culture. In this role, a typical day might include the following: Working in conjunction 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. This includes: Designing and developing 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 Build awareness through engagement with employees of the need for and the desire to build and role model a mature DG culture Act as DG advocates with Data Stewards on the culture and behavioural changes required, why, and steps that can be taken to develop an open and transparent DG culture Responsible for gathering agreed site DG KPIs, reporting their findings to the DG Business Partners for the relevant area Establish ongoing monitoring and auditing processes to ensure DG cultural improvements are sustained 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: 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 Does this sound like you? Apply now to take your first step towards living the Regeneron Way 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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