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, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Position Summary: Responsible for supporting, overseeing and presenting on the IOPS (Industrial Operations and Product Supply) Technical Training Compliance program. This position will assist in the identification and implementation of training compliance opportunities to meet IOPS standards and applicable GxP regulations.
Essential Duties and Responsibilities may include, but are not limited to, the following:
- Provides leadership and ensures continuous improvement to the Quality Training System and the GxP Program according to GxP and current industry standards.
- Provides guidance to the internal Technical Training team as well as functional areas executing and documenting training to ensure understanding and compliance of all IOPS and applicable GxP training requirements.
- Participates as a stakeholder on initiatives to implement or change IOPS training systems, procedures and policies as needed.
- Participates in quality systems activities such as internal audits, inspection preparation, inspection presentation and change control.
- Supports internal and external requests for training compliance evidence.
- Conducts training compliance monitoring and reviews outcomes with functional areas.
- Develops and reports on training compliance metrics to measure the overall training strategy.
- Interfaces with all good manufacturing practices groups and key stakeholders to provide support and oversight of training compliance.
- Supports functional areas with the evaluation of deviations related to training compliance.
- Supports fulfillment of the IOPS Annual Training Plan including an Ongoing GxP refresher program.
- Remains current and knowledgeable of key aspects of new or amended regulations and guidelines impacting training by studying existing and new legislation and advising management on needed actions.
- Supports IOPS Technical Training and organizational training initiatives.
Knowledge, Skills, and Abilities:
- Current and knowledgeable of key aspects GxP regulations and guidelines.
- Knowledge of IOPS Quality Systems preferred.
- Excellent written, verbal and interpersonal communication skills.
- Ability to communicate at all levels and across various functions.
- Ability to present to a large or small group.
- Ability to manage internal and external relationships.
- Ability to handle multiple projects and priorities with exceptional organizational and time management skills.
- Identify and effectively communicate risks.
- Ability to define problems, collect and analyze data, establish facts, and draw valid conclusions.
Education and Experience:
- Requires BS/BA in related field, knowledge of GxP requirements, and 8+ years of relevant experience in the pharmaceutical/biotechnology industry. Related experience may be substituted in lieu of education.
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.