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 with integrated gene editing, delivery and 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 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 Senior Manager, Compliance and Training, will provide expertise in training design and execution for Beam and support overall training management. This role is specifically responsible for developing, implementing, and administering global training while supporting the application of Global Quality Policies & Standards, Change Controls, and Deviation/Corrective and Preventive Action review and administration.
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 Senior Manager, Compliance and Training will provide training, training system technical support and expertise in training processes, procedures, and operational activities to Quality Systems users globally which includes, but is not limited to, System Training Development, Metrics, Application of Global Quality Policies & Standards. 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 Senior Manager, Compliance and Training is a key contributor role and reports to the Associate Director, Quality Systems and Compliance. This position is expected to be on-site three days a week.
Primary 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.
Qualifications:
- University degree in scientific discipline/Life Sciences or equivalent experience in the biotech or pharmaceutical industry.
- 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.
- 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.
- Good listening and communication skills.
- Positive approach.
