Director GMP Data Governance
1 day ago
Your role is fundamental in ensuring Regeneron's data is effectively managed and utilised whilst remaining compliant with regulatory requirements. You will play a key role in fostering a data compliance culture and being accountable for developing comprehensive Data Governance (DG) policies and procedures across the organization. You will monitor the adoption of these policies and stay abreast of industry trends, technology advancements and external compliance decisions. Your remit will include supporting internal data audits, ensuring inspection readiness and governance related to IOPS related acquisitions. In this role, a typical day might include the following: Generation of policies and procedures based on current and evolving global standards, ensuring global IOPS alignment and adjusting established policies and practices Responsible with Site Leads for the creation and definition of KPIs Accountable for senior leadership stakeholder engagement and holding the business to account in meeting the standards set Accountable for Program Management and ensuring the DG (Policies & Programs) team is appropriately resourced, supported and has the tools and direction to properly execute their function Establishing a successful relationship with Site Leads and their teams so a clear feedback loop is established Supporting the preparation for regulatory inspections and audits related to DG by ensuring that policies, procedures, and documentation are up-to-date and compliant Assessing and integrating DG practices in the context of IOPS related mergers, acquisitions, and partnerships Fostering a culture of quality & DG within the organisation and promoting the importance of data accuracy, reliability and transparency across all departments Facilitating 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 Demonstrable ability to oversee the creation of global policies, procedures and standards both with and through the business Extensive experience demonstrating the ability to partner, influence and incorporate new standards Extensive experience in changing / revising large-scale program initiatives in the pharmaceutical or biotechnology industry Experience leading cross functional teams and managing enterprise-wide data programs, operating and influencing across a global organization Experience in integrating cross-corporate processes, information strategies and/or designing strategic metrics and scorecards Strong analytical and problem-solving skills with exceptional attention to detail Excellent communication and presentation skills, with the ability to convey complex concepts to non-technical audiences The ability to adapt in the face of changing business needs Recent leadership experience in a data integrity or data governance role 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 Occasional travel to the US site required 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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1 day ago
Limerick, Ireland Regeneron Ireland DAC Full timeThe Principal GMP Data Governance Specialist plays a pivotal part in ensuring that Regeneron's Data Governance (DG) systems and practices meet the highest standards of regulatory and industry compliance. You will beresponsible for providing specialised knowledge and expertise in the design of (DG) frameworks, policies and procedures that are aligned with...
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Limerick, Ireland Regeneron Ireland DAC Full timeThis 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...
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