Associate Director, Quality Control

About this role

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:

We are seeking an Associate Director, Quality Control to lead the Beam Massachusetts Quality Control team in delivering compliant, scientifically sound, and timely GMP testing while maintaining a continuous state of laboratory and inspection readiness. This on-site role will provide site-based QC leadership for routine GMP testing operations supporting Beam’s clinical and late-stage programs, and will help support the team’s transition from a clinical-stage QC group to a late-stage, commercial QC operation.

The successful candidate will be responsible for leading a team performing release, stability, method qualification/validation, and method transfer testing while ensuring that analytical methods, laboratory equipment, LIMS/LES builds, method templates, reagents, reference standards, sample workflows, documentation, training, audit trails, and data systems remain ready for GMP use and regulatory inspection. Additionally, the Associate Director will own or oversee key QC quality systems, including deviations, laboratory investigations, change controls, CAPAs, effectiveness checks, and continuous improvement initiatives.

The position will also play a critical role in supporting commercial and BLA readiness by ensuring the Massachusetts QC laboratory is prepared to support regulatory inspections, routine clinical product testing, quality-system execution, and ongoing laboratory performance improvement. The role requires a strong leader who can balance daily testing execution, compliance rigor, scientific judgment, staff development, cross-functional influence, and long-term operational readiness.

Primary Responsibilities:

• Lead the Massachusetts QC organization to ensure timely, compliant, and scientifically sound execution of GMP testing, including release, stability, method qualification/validation, and method transfer testing.

• Provide direct leadership and oversight for QC staff performing routine GMP testing, data review, laboratory investigations, method troubleshooting, and inspection support.

• Ensure the QC laboratory remains in a continuous state of inspection readiness, including readiness of methods, instruments, data systems, documentation, training records, audit trails, analyst qualifications, and SME preparation.

• Own or oversee QC quality-system records and processes, including deviations, laboratory investigations, change controls, CAPAs, effectiveness checks, and continuous improvement actions.

• Partner with Data Integrity and Quality Systems to ensure GMP data meet ALCOA+ principles and remain complete, consistent, accurate, attributable, legible, contemporaneous, original or true copy, and secure throughout the data lifecycle.

• Maintain analytical method and laboratory readiness by ensuring appropriate control of analytical equipment, LIMS/LES builds, method templates, reagents, reference standards, sample workflows, and supporting documentation.

• Ensure QC testing operations are appropriately planned and resourced to support clinical manufacturing, release timelines, stability commitments, method lifecycle activities, and commercial/BLA readiness.

• Use quality metrics, recurring deviations, invalid assay trends, audit observations, capacity constraints, and inspection-readiness commitments to drive continuous improvement and reduce compliance risk.

• Provide leadership for laboratory issue resolution, including escalation of testing delays, equipment constraints, data integrity risks, investigation trends, method performance issues, and quality-system bottlenecks.

• Ensure team members are trained and qualified for GMP activities, including method execution, data review, deviation support, documentation practices, inspection interactions, and applicable data integrity expectations.

• Coach and develop QC staff, including supporting individual development plans, technical growth, career development, succession planning, and readiness for expanded responsibilities.

• Serve as a key QC interface with QA, Manufacturing, MS&T, Analytical Research & Development, Regulatory Affairs, Supply Chain, LabOps, CSV, CQV, IT, Quality Systems, and other cross-functional partners.

• Support preparation for regulatory inspections, mock inspections, health authority interactions, and internal/external audits by ensuring QC records, SMEs, laboratory systems, and supporting evidence are inspection-ready.

• Provide clear communication to site and functional leadership regarding QC operational status, quality-system commitments, inspection-readiness risks, resource needs, and critical path activities.

Qualifications:

• Advanced degree, or equivalent experience, in Chemistry, Biochemistry, Molecular Biology, Cell Biology, Analytical Sciences, Pharmaceutical Sciences, or a related scientific discipline.

• 8+ years of relevant industry experience in Quality Control within biologics, cell therapy, gene therapy, mRNA, or other complex therapeutic modalities.

• Prior experience leading or managing a GMP Quality Control laboratory team responsible for routine testing, data revie

Similar jobs

• Associate Director, Quality Operations — Amylyx · Cambridge, MA
• Associate Director, Quality Assurance Compliance — Gilead Sciences · Foster City, California, United States | United States – Remote
• Director, Quality Control — Dynetherapeutics · Waltham, MA
• Director, Quality Control — Corcepttherapeutics · Redwood City, California, United States
• Director, Quality Control — Crusoe · Dallas, TX - US
• Director, Quality Control — Ferring · Parsippany, New Jersey, United States
• Associate Director, Technical Operations Quality Control — Travere Therapeutics · Remote
• Associate Director Quality Assurance — Becton Dickinson · USA TX - El Paso - Northwestern Dr.