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Principal Training Program Optimization Specialist

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, NY, United States
Start date
Oct 15, 2020

View more

Discipline
Administration, Training, Clinical
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

Summary: Influence the continuous improvement of a GxP training program based on regulatory requirements and reinforcing a quality culture. Immerse GxP principles into the DNA of the Regeneron Pharmaceuticals Industrial Operations and Product Supply (IOPS) organization.

Essential Duties and Responsibilities may include, but are not limited to, the following:
• Develop and implement new approaches and enhancements to the IOPS GxP training program
• Seed GxP Quality Culture into all facets of the IOPS organization
• Evaluate the regulations and industry trends to identify opportunities to strengthen the GxP training program
• Collect and analyze data, establish facts and identify opportunities for improvement
• Conduct GxP Training monitoring and review outcomes with functional areas
• Identify and effectively communicate risks
• Develops and writes advanced reports for the GxP training program
• Organize, facilitate and present training sessions to groups or individuals as needed
• Ability to handle multiple projects and priorities with exceptional organizational and time management skills
• Supports IOPS Technical Training and organizational training initiatives
• Supports fulfillment of the IOPS Annual Training Plan and approves content

Goal of the position:
• Evaluate the current GxP training program and identify opportunities beyond onboarding and ongoing refresher training while promoting continuous improvement
• Support the regulatory requirement for personnel to have: Training, Experience and Education; with specific emphasis on Education

Knowledge, Skills, and Abilities:
• A versatile, high energy, thinker, and self-motivated individual
• Understands and can apply human performance fundamentals
• Excellent written, verbal and interpersonal communication skills
• Ability to take a big idea and make it happen
• Ability to use data to drive results
• Ability to negotiate and influence without authority
• Proven project management experience
• Ability to embody to the IOPS culture

Education and Experience:
• Principal Level - Requires BS/BA in related field, in-depth knowledge of GxP requirements, and 8+ years of relevant experience in the pharmaceutical/biotechnology or a highly regulated industry. Related experience may be substituted in lieu of education.
• Staff Level - Requires BS/BA in related field, in-depth knowledge of GxP requirements, and 10+ years of relevant experience in the pharmaceutical/biotechnology or a highly regulated industry. Related experience may be substituted in lieu of education.
• Experience shaping a GxP training program, reinforcing, and developing innovative solutions for a Quality Culture
• Experience with GxP Quality Systems preferred

Level to be determined based on qualifications relevant to the role

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.INDIOPS
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Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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