Associate Director, QC Analytics & External Partnerships

Viridian Therapeutics

Waltham (MA)

Hybrid

USD 163,000 - 200,000

Full time

14 hours ago
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Benefits offered by this job

Competitive pay and stock options
Medical, dental, and vision insurance
401(k) Company Match
Paid vacation and holidays

Job summary

Viridian Therapeutics, based in Waltham, MA, is seeking an Associate Director of Quality Control to lead the QC Analytical team and coordinate with CMOs and CTLs. The role focuses on governance of analytical methods, data integrity, and regulatory readiness for clinical and commercial programs.

You will oversee method lifecycle activities, collaborate across functions, and prepare for IND/BLA submissions while ensuring timely QC deliverables and compliance with global regulations.

Qualifications

  • Master’s or equivalent with 8+ years in QC/analytical development.
  • Experience with biologics QC method lifecycle (transfer, validation, monitoring).
  • Experience with external CMOs/CTLs and contract labs.
  • Strong communication skills and regulatory inspection experience.
  • Travel up to 10%.

Responsibilities

  • Provide strategic leadership to QC Analytical team and external partners.
  • Develop specifications, reference standards, reagents per global regs.
  • Analyze complex analytical data for stakeholders and leadership.
  • Lead method lifecycle management and transfers.
  • Support regulatory submissions and inspection readiness.

Skills

QC analytical methods
Statistical analysis
Regulatory inspections experience
Contract labs oversight
Communication skills
Data integrity
Travel up to 10%

Education

Master’s degree
Bachelor’s degree

Tools

HPLC/UPLC
ELISA
Spectroscopy
Data analysis tools (JMP)

Job description

Viridian Therapeutics, based in Waltham, MA, is seeking an Associate Director of Quality Control to lead the QC Analytical team and coordinate with CMOs and CTLs. The role focuses on governance of analytical methods, data integrity, and regulatory readiness for clinical and commercial programs.

You will oversee method lifecycle activities, collaborate across functions, and prepare for IND/BLA submissions while ensuring timely QC deliverables and compliance with global regulations.

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