Manager/Sr. Manager, Global Compliance and Training

The Manager/Sr. Manager, Compliance and Training, will provide expertise in training design and execution for Beam and support overall training management. This role is critical to Beam's support of 21 CFR 211.25, which requires that personnel have the necessary education, training, and experience for their roles, including training in GMPs related to their functions.

Requirements

• University degree 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 with at least 3 years of demonstrated experience with the development, maintenance, and training oversight required.
• General knowledge of regulatory requirements for the pharmaceutical, biotechnology, or vaccine industry.
• 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.
• Veeva experience required.
• Formal or technical writing experience.
• Highly attentive to details and able to work well as part of a team.
• Demonstrates consistent judgment, quality, accuracy, speed, and creativity.
• Understands, selects, and uses appropriate risk management and root cause analysis tools.
• Takes initiative in making improvement suggestions to promote operational goals.
• Applies Quality concepts and company policies to resolve issues of moderate complexity in an effective manner.
• Facilitates designing processes with Quality built in from the beginning.
• Identifies and uses good judgement to handle out-of-compliance situations.
• Good listening and communication skills.
• Positive approach.