Beam Therapeutics
Senior Manager, Compliance and Training
Durham, NC · Senior · Full-time
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About the role
- Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines.
- To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities.
- This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs.
Responsibilities
- Develops, leads, and implements training initiatives that are aligned with business strategies.
- Design, develop and deliver instructional materials, both digital and physical, in an efficient, effective, appealing, engaging way.
- Manages the performance/effectiveness of quality system training programs.
- Work collaboratively on the GXP integrated digital landscape to support, resolve system technical issues and communicate best practices for electronic quality training systems.
- Assist in the refinement of system user training and support training delivery.
- Support site and function audit preparations with respect to system functionality.
- Support development of harmonized/streamlined/standardized processes and supplemental documents (including Work Instruction creation or maintenance) governing management and usage of Quality Systems.
- Maintain system-related metrics and assist in analyzing training effectiveness based on those metrics.
- Ability to own appropriate and complete system Quality Events (Issues, Change Controls and CAPAs) to meet internal procedures and regulatory expectations.
- Develops user requirements regarding Quality training systems and supports the generation/review/approval of computer system validation deliverables.
Requirements
- BS in scientific discipline/Life Sciences or equivalent experience in the biotech or pharmaceutical industry.
- Typically 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.
- Ability to work independently.
- Excellent computer skills and advanced knowledge of Quality Systems.
- Self-motivator with the ability to follow up on and complete multiple projects simultaneously.
- 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.
- 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.
- 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.
Compensation
- The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting.
This listing is sourced directly from Beam Therapeutics's careers page and normalized into a canonical job model.