Working under the Quality Assurance organization this position is responsible for ensuring IT systems, programs and quality events are robust and meet regulatory agency expectations. The position will liase with the IT and broader QA organizations to ensure all aspects of IT related programs are in compliance with regulatory agency expectations and internal company policies and procedures.Essential Duties and Responsibilities include, but are not limited to, the following:Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvementsReviews, edits and approves deviation notifications, deviation investigations, and corrective actionsReviews, edits and approves change control and SOPsParticipate and support the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives.Support the development, review and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process.Presents and/or defends at both internal and external (regulatory) audits and presents in a “pressure test” scenario the technical area that they are SME.Collaborates, investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.Achieves quality objectives by contributing information reflecting best practices in the industry and recommendations to strategic plans and reviews.Stays current with industry trends and regulatory requirement updates and drives changes and improvements based on trends.Presents project and program status and metrics to Senior Management.Acts as Technical Subject Matter Expert (SME).Leads special projects as assigned.Trains and advises less experienced personnel.May have direct reports.Performs other duties assigned by Management.Some travel may be required (approximately 25%).Education and Experience:Specialist: Requires BA/BS degree and 2 years of experience or equivalent combination of education and experienceSenior Specialist: Requires BA/BS degree and 5 years of experience or equivalent combination of education and experienceRecent experience in a data integrity role is preferred; however, it is not required. Focus is on aptitude and capability – data integrity training can be provided for the right candidateKnowledge, Skills, and Abilities:Knowledge of 21CFR11 and Annex 11 as well MHRA, FDA and WHO data integrity guidelines.Knowledge and experience with Computer Systems Validation and/or IT AuditingUnderstanding of the interdependencies of change management, deviation and continuous improvement. Ability to define a vision and implement interim milestones.Ability to work in a dynamic organization where innovative solutions are required to ensure a high-level of quality is achieved with aggressive timelines.Knowledge of global organizations, process mapping and process improvement.Knowledge of applicable federal, state and local regulations, rules, policies and proceduresAbility to gather relevant facts, assess, and decide to execute; understands impact to areas and seeks inputSkilled in analyzing information of considerable difficulty and drawing valid conclusionsComfortable navigating ambiguity with the ability to help define actions#LI-Onsite #JOBSIEST #IRELIM #REGNIEQADoes 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.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.
