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Beam Therapeutics · 1 month ago

Manager/Sr. Manager, Global Compliance and Training

Durham, NC

Full-time

Onsite

Senior Level, Lead/Staff

$125K/yr - $190K/yr

8+ years exp

Beam Therapeutics is a biotechnology company focused on precision genetic medicines. The Manager/Sr. Manager, Compliance and Training will develop and implement global training initiatives while ensuring compliance with quality policies and standards in a GMP environment.

BiotechnologyGeneticsMedicalTherapeutics

Comp. & Benefits

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

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

Develops user requirements regarding Quality training systems and supports the generation/review/approval of computer system validation deliverables

Contributes to the generation, review, and approval of computer system test scripts

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

Provides quality assurance guidance in a professional and collaborative manner to stakeholders

Qualification

GMPGXP experienceQuality Management SystemsTraining development oversightRegulatory knowledgeVeeva experienceRisk management toolsInterpersonal skillsTechnical writingCommunication skills

Required

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

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

Veeva experience required

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

Good listening and communication skills

Positive approach