Associate Director, Quality Systems and Compliance

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 Systems.

• Cross-functional: Collaborate with Commercial, Procurement, and Quality functions to ensure compliant strategies.

Qualifications:

• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry, or related discipline, or its equivalent, is preferred.
• 12+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality, with 4+ years’ experience working with Veeva.
• Direct experience with managing commercial treatment centers and executing audits.
• ASQ CQA audit certification is preferred.
• Working knowledge of US and EU cGMP regulations and guidance including knowledge of FACT and JACIE accreditation.
• Experience interacting with regulatory health authorities’ inspections.
• Excellent verbal and written communication skills (technical writing), detail-oriented personality, and ability to work collaboratively across functions.
• Knowledge of aseptic processing/cell culture/cell and gene therapy manufacturing, and analytical testing is preferred.
• Applies Quality concepts to resolve issues of moderate complexity in an effective manner.
• Strong, positive team player who has a customer service approach and is solution-oriented.
• Attention to detail and adherence to timelines.
• Experience with Lean Manufacturing and/or Continuous Improvement efforts.
• Ability to communicate throughout all levels of the organization.
• Independently troubleshoots problems and issues; called upon to train or assist others for a large portion of the job.