ComplianceWire (Learning Management System) System Owner/Administrator
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: Responsible for performing a variety of complex tasks under general guidance and in compliance with cGMPs. Responsible for the learning management system (LMS), related Training documentation, and the management of the LMS. This position also serves as the Learning Management System (LMS) Subject Matter Expert by providing support of the day-to-day ongoing operation, maintenance, usage, analysis and administration of the LMS. Also responsible for leading a group of Technical Training professionals, setting and communicating the vision for the group, and fostering a culture of collaboration in a global organization.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Manages data reporting mechanism to generate detailed training completion reports for area managers and site management reviews. These reports are also used to provide employee training compliance evidence requested during Regeneron's regulatory audits.
• Develops strong partnerships and communicate with numerous functional areas to define business requirements as it relates to Training Quality System and the Learning Management System (LMS).
• Maintains strong relationships with key business leaders to ensure acceptance and operational applicability of key LMS's operational processes, procedures and training materials.
• Oversees all aspects of Rensselaer (IOPS) Learning management System (LMS) and its operational processes, procedures and training materials.
• Participates in cross functional / sites' Technical Training teams to identify departmental goals, objectives and metrics in alignment of IOPS Technical Training strategy.
• Develops deep understanding of employee GMP training needs and aligns organization on the strategies to address those needs via effective communication.
• Mentors and develops Rensselaer Technical Training department staff.
• Manages and oversees the e-Learning specialists on department projects and initiatives.
• Serves as a role model for behavior that is consistent with the mission, vision and values of the Regeneron organization with respect to quality, safety, efficiency, compliance and collaboration.
• Recommends, negotiates and maintains training vendor contracts and ensures relationships are managed in an effective manner.
• Conducts internal audits and monitors employee training to ensure that all employees are in compliance.
• Serves as an LMS SME or spoke person for Technical Training during a regulatory inspection.
• Provides training/user support for LMS end users and administrators.
Knowledge and Skills:
• Extensive knowledge regarding ComplianceWire Learning Management Systems (LMS) and its operational processes.
• Proven ability to formulate a compelling vision and develop a strategy with key stakeholders to achieve that vision.
• History of building and maintaining positive relationships both internally and externally.
• Proven ability to influence and motivate cross-functional teams.
• Strong communicator with excellent verbal, written and presentation skills.
• Can negotiate skillfully in tough situations with both internal and external groups.
• Strong business acumen, client-service and results orientation.
• Highly effective in ambiguous environment and able to produce maximum results with little direction and guidance.
• Strong understanding of quality principles in a GMP environment helpful.
Education and Experience:
• Requires BS/BA degree in related field required along with a minimum of 8 years of progressive relevant experience.
• Direct GMP training experience in the pharmaceutical or biotechnology industry preferred, but not required.
• Previous direct managerial experience required.
Title level will be determined based on skills and experience.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Requisition Number: 12901BR