Associate Director, Quality Systems and Compliance

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:

Beam is seeking a highly talented and motivated Associate Director to join our Compliance and Quality Systems team. The Associate Director serves as the enterprise owner of treatment center onboarding and quality integration, ensuring the efficient, compliant, and scalable activation of commercial treatment centers across the network. This role develops and leads the end-to-end onboarding strategy, coordinating cross-functional stakeholders to accelerate treatment center readiness while maintaining the highest standards of quality, compliance, and operational excellence. As the single business owner for all treatment center agreements, the Associate Director provides governance over quality assessments, quality agreements, periodic re-evaluations, and related documentation, driving timely execution and risk mitigation. The position is accountable for establishing streamlined processes, performance metrics, and communication pathways that prevent onboarding bottlenecks, reduce handoff-related risks, and enhance the treatment center experience. Additionally, this role leads continuous improvement initiatives through SOP, work instruction, and training development, while leveraging quality evaluations, gap analyses, and best-practice sharing to strengthen treatment center capabilities and support long-term commercial growth. This role will support cross-functional operations to ensure that systems and processes are compliant with GxP compliance areas (GLP, GCP, GMP, GDP, GVP) as the programs move from clinical to the commercial phase.

This role will work with all sites and functions to ensure initiatives related to these areas are optimized and executed appropriately.

This is a full-time position that is based in Beam NC, with up to 25% potential travel.

Responsibilities:

Qualification: Lead and manage both the onboarding and qualification process for new and existing commercial suppliers (e.g., treatment centers and transportation providers), including pre-classifications and quality system evaluations/reevaluations including identification of quality risks and development of mitigation strategies.

Auditing: Conduct on-site and remote audits of treatment centers, manage audit reportings/findings, and track Corrective and Preventive Actions (CAPAs) to closure.

Agreement Management: Draft, negotiate, and maintain Quality and Technical Agreements.

Risk Management: Maintain oversight of treatment centers, identifying supply and quality risks while developing proactive mitigation strategies.

Performance Monitoring:

Track treatment centers metrics, handle escalations (e.g., log, assess, investigate, and close), and process change notifications.

Drives continuous improvement on expectations regarding adherence to SOPs, ensuring compliance with timelines and due dates, engaging the correct stakeholders, and improving Quality Event KPIs.

Participate in the continuous improvement of applicable quality systems for Beam; identify potential gaps or improvements, and own and drive solutions as needed.

Compliance:

Ensure all treatment centers records and documentation adhere to FDA 21 CFR regulations and internal Quality Management Systems (eQMS).

Identify potential compliance issues and task corrective measures to prevent them, participating on assigned teams as required.

Maintain and update the Qualified Supplier List (QSL).

Ensuring organization is prepared for regulatory inspections including pre-approval inspections, audits, and inspections by external bodies, focusing on documentation, training, and maintaining compliance.

Providing data for Senior Management Meetings (not limited to, Quality Management Review and Quality Council, GMP QA/Quality Functional review forums).

Developing and delivering training programs to ensure employees are trained on inspection readiness procedures and regulatory requirements.

Support the development of harmonized/streamlined/standardized processes and supplemental documents (including Work Instructions created or maintained) governing the management and usage of Quality Syst…