Associate Director - Quality Control

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.
• Typically 10+ years of experience with 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 review, investigations, method execution, and inspection readiness.
• Strong understanding of GMP laboratory operations, including release testing, stability testing, in-process testing, method qualification/validation, method transfer, sample management, equipment readiness, and laboratory documentation.
• Demonstrated experience with quality systems, including deviations, laboratory investigations, change controls, CAPAs, effectiveness checks, root cause analysis, and continuous improvement.
• Working knowledge of data integrity expectations, including ALCOA+ principles, audit trail review, computerized system controls, electronic records, validated spreadsheets, data lifecycle management, and inspection expectations for GMP data.
• Experience supporting regulatory inspections, mock inspections, internal audits, or inspection-readiness remediation activities in a GMP laboratory environment.
• Demonstrated ability to lead cross-functional issue resolution involving QC, QA, Manufacturing, MS&T, Analytical Research & Development, Regulatory Affairs, Supply Chain, LabOps, CSV, CQV, IT, and Quality Systems.
• Strong technical judgment and problem-solving skills, with the ability to assess risk, interpret laboratory data, identify trends, support investigations, and translate findings into practical corrective and preventive actions.
• Proven ability to manage competing priorities across routine testing, quality-system commitments, method readiness, inspection readiness, and staff development.
• Excellent written and verbal communication skills, including the ability to clearly communicate technical, operational, and compliance topics to senior leaders, cross-functional teams, auditors, and regulatory inspectors.
• This is an on-site role at the Beam Therapeutics Quality Control laboratory in Cambridge, MA.

Beam Pay Range 185000 - 225000 USD