Senior Manager, Compliance and Training

The role

The Senior Manager, Compliance and Training will provide expertise in training design and execution and support overall training management. This role develops, implements, and administers global training while supporting Global Quality Policies, Change Controls, and Deviation/CAPA review.

What you will do

• Develops, leads, and implements training initiatives aligned with business strategies.
• Design, develop and deliver digital and physical instructional materials.
• Manages the performance and effectiveness of quality system training programs.
• Supports the GXP integrated digital landscape to resolve system technical issues.
• Assists in the refinement of system user training and support training delivery.
• Improves and maintains the overall Quality Management System (QMS).
• Develops user requirements for Quality training systems and supports computer system validation deliverables.
• Contributes to the generation, review, and approval of computer system test scripts.
• Supports site and function audit preparations regarding system functionality.
• Maintains system-related metrics and analyzes training effectiveness.

Required qualifications

• BS in scientific discipline/Life Sciences or equivalent experience in the biotech or pharmaceutical industry.
• 8+ years of relevant experience in a GMP and GXP environment.
• At least 3 years of demonstrated experience with the development, maintenance, and training oversight.
• General knowledge of regulatory requirements for the pharmaceutical, biotechnology, or vaccine industry.
• Skilled in determining the state and needs of the learner and defining the end goal of instruction.
• Excellent interpersonal effectiveness, written/verbal communication, influencing, and negotiation skills.
• Ability to work independently.
• Excellent computer skills and advanced knowledge of Quality Systems.
• Direct experience with Quality Management Systems, Document Management Systems, Learning Management Systems, and Microsoft Office, including Word and Excel.
• Self-motivator with the ability to follow up on and complete multiple projects simultaneously.
• Formal or technical writing experience.
• Highly attentive to details and able to work well as part of a team.

About the company

Beam Therapeutics is a biotechnology company committed to establishing a platform for precision genetic medicines using base editing technology. It is a values-driven organization focused on providing life-long cures to patients with serious diseases.