Company Overview:

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 that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview:

The Specialist I/II, Compliance and Training, will oversee the day-to-day operations of our Learning Management System (LMS), support training program development, and partner with cross-functional teams within Beam and support the Sr Manager. This role is specifically responsible for supporting the development of NC training materials and knowledge assessments for key processes and systems while administering global training.

The position 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.

The Specialist I/II, Compliance and Training will provide training and expertise in training processes, procedures, and operational activities to Quality Systems users globally. This role will support key stakeholders in ensuring compliance with training for phase-appropriate GxPs, global HR/Legal/regulatory training, and applicable global policies.

This role works cross-functionally and serves as a liaison between the Global Quality System and Compliance team and Beam. The Specialist I/II, Compliance and Training is a key contributor role and reports to the Sr Manager, Quality Systems and Compliance. This position is expected to be on-site three days a week.

Primary Responsibilities:

• Design and deliver instructional materials, both digital and physical, in an efficient, effective, appealing, engaging way.
• Assist with managing and evaluating the performance/effectiveness of quality system training programs.
• Manage NC day-to-day operations of the site Learning Management System (LMS), including auditing, reporting, and compliance monitoring.
• Partner with functional areas to assess training compliance, perform effectiveness checks, and track trends.
• Lead annual curriculum audits and provide guidance to department leaders.
• Create and maintain site-level curricula, job aids, and training documentation.
• Support line management with project coordination, review of training content, and oversight of annual GMP/GDocP training.
• Deliver training for Visual Inspection, MES, gowning, etc., as needed.
• Facilitate Durham BTEC grant for Beam.
• Monitor training program effectiveness and identify opportunities for continuous improvement.
• Assist in improving and maintaining Beam’s overall Quality Management System (QMS), including policies and procedures, while keeping them current with emerging and changing regulations.
• 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.
• Perform as System Coordinator including:
  • Executing training administration of document change control workflow for Controlled Documents.
  • Contact for basic technical questions relating to the use of the training portion of the document management system globally.
  • Support to functional department SMEs to develop and maintain functional level training content and curricula.

Qualifications:

• University degree in scientific discipline/Life Sciences or equivalent experience in the biotech or pharmaceutical industry or 10+ 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.
• 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 with good listening and communication 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.
• 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.
• 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.
• Positive approach.