Associate Director, Quality Control
Beam Therapeutics · Cambridge, MA · $185k–$225k
Posted by Beam Therapeutics on their careers site · View the original posting
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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 cont
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rocess 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.
The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.
Beam Pay Range
$185,000 — $225,000 USD