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. 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.S.-based 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. #J-18808-Ljbffr
In this role you will be responsible for the implementation of data governance (DG) standards, policies and procedures into business operations. You will be a site resource and subject matter expert on good DG practices and ensure Business Groups are aligned to the IOPS Data Governance Program. Your remit will involve supporting the Regeneron Industrial Operations and Product Supply (IOPS) Data Governance and Integrity program. In this role, a typical day might include the following: Implementation of standards, policies and procedures within allocated areas of the business Be the allocated business area(s) key DG contact providing support and advice and engage with the allocated business unit on DG priorities and action plans Assess allocated business unit's current policies and processes and oversee the achievement of local DG KPIs Conduct regular data audits and assessments to identify DG issues and work with business area to prepare for DG auditing and inspections Work in partnership with other DG Business Partners, Technical DG Experts & ECM Experts to deliver on the DG plan and feedback themes to allow continuous improvement and evolution of the DG approach 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 Encouraging CI by actively seeking feedback and supporting initiatives designed to enhance data quality and governance 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: 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 Demonstrated success in implementing and managing policies and standards within a regulated environment Excellent communication and collaboration skills Strong stakeholder management and influencing skills Experience in use of quality systems and/or change management To be considered for this role you must hold a BA/BS degree and 7+ 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. 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. #J-18808-Ljbffr
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. 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. 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. #J-18808-Ljbffr
This leadership role is fundamental in creating, building & motivating a global Data Governance (DG) team responsible for maintaining compliance with regulatory standards. It offers an opportunity to shape the DG landscape of Regeneron, driving innovation and excellence through data. The role will suit a visionary leader with a passion for data and a track record for driving success. The post-holder will set and implement a strategic vision for Regeneron's data maturity roadmap including policies & procedures. They will lead the required change management program to enable the creation and embedding of a sustainable data quality culture across the organization. They will also be accountable for the Regeneron Industrial Operations and Product Supply (IOPS) DG program & serve as the global leader and subject matter expert on DG practices. In this role, a typical day might include the following: The creation & delivery of IOPS' DG Program (Strategy, Engagement, Culture & Monitoring & Data Ops Leadership) for current and future sites & partners Adhering to current & evolving global standards using regulatory guidance & industrial intelligence, & generation of policies and procedures Senior Leadership Team (SLT) stakeholder engagement & holding the business to account in meeting the standards set Program Management Ensuring right to operate DG standards are continuously met Leading, driving and supporting with and through the business a mature DG culture Ensuring the DG function is appropriately resourced (internal & contract), supported and has the tools & direction to properly execute their function Delivering role model behaviors in promoting a DG culture across the organisation Staying updated on latest industry trends, regulatory changes and enforcement actions within the biopharma industry and assessing the impact of these within IOPS Fostering a culture of quality & DG within the organisation Promoting the importance of DG across all departments Driving communication and collaboration between stakeholders to ensure effective DG practices Encouraging CI by actively seeking feedback and supporting initiatives designed to enhance data quality and governance 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: Experience demonstrating the ability to partner, influence and incorporate new standards, or extensive experience in changing / revising large-scale program initiatives in the pharmaceutical or biotechnology industry Recent leadership experience in a data integrity or data governance role Previous people management and/or team leadership experience Experience leading cross functional teams and managing enterprise-wide data programs, operating and influencing across a global organization Significant leading change experience Experience in integrating cross-corporate processes, information strategies and designing strategic metrics and scorecards Demonstrated 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 working knowledge of laboratory, manufacturing and support systems, and associated business processes Experience in a Quality organization (quality systems) and/or Manufacturing operations (Automation) An understanding and experience in agile methodologies (ex. Lean thinking, Agile methodology, Design thinking, Six sigma, etc.) To be considered for this role you must hold a BA/BS degree and the following amount of relevant experience for each level: Sr Director: 15+ years Executive Director: 20+ years 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 will also be considered. 50% travel required between sites based in Ireland and the USA. #J-18808-Ljbffr
