Associate Director, Training Compliance

Job Description

The Associate Director, Training Compliance will apply business knowledge, cGMP and training requirement expertise to develop and manage a strategy for Global Training Compliance. The incumbent will provide a high level of Quality oversight to training content and training programs across PO&T and serve to ensure compliance to relevant regulatory requirements as well as Biogen needs. The role with partner closely with PO&T learning partners at sites and functions to ensure training process meets compliance requirements and align on global improvements.

This is a hybrid role based at our RTP, NC offices. 

What You'll Do 

• Serve as a strategic partner to provide Quality oversight and support over Training system. Defines and manages associated standards, practices, processes, programs and projects related to training.
• Partner with Learning leads at Biogen sites and functions to implement cGMP compliant training programs according to need. Creates and monitors controls for fitness and improvements.
• Oversee learning content compliance for corporate quality. Manage assignment profiles and curriculum to ensure compliance to business line function needs. Ensures site/functional learning leads own and ensure training process, adherence, reporting and compliance at sites.
• Develop and oversee the implementation of assessment and evaluation tools to measure effectiveness of training. Manage key KPIs and report out to QLT and PO&T leaders on the compliance to assigned curricula, with support from site and functional learning leads.
• Provide strategic business direction for the compliance of long term training programs. Participate in goal setting and ensure customer, personnel and business needs are met.

Who You Are  

You have hands-on experience and intimate knowledge of FDA and International regulations around training and cGMP. You have worked in a cGMP environment and have a passion for learning.

Qualifications

Required Skills  

• Bachelor’s Degree with 8 to 10 years of experience in the pharmaceutical industry with minimum 5 years in a training oversight role
• cGMP knowledge and understanding of FDA Regulations
• Basic understanding of adult learning techniques
• Ability to communicate on all levels, strong cross functional leader 
• Knowledge of industry standard and ability to develop useful KPIs 

Preferred Skills 

• Quality Assurance in Pharmaceutical or Biotech

Additional Information

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.