Associate Director, Investigations Excellence & Readiness

Moderna Therapeutics

Norwood (MA)

On-site

USD 143,000 - 257,000

Full time

7 days ago
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Benefits offered by this job

Healthcare
Well-being programs
Family planning benefits
Generous paid time off
Retirement savings plan

Job summary

Moderna Therapeutics in Norwood, MA seeks an Associate Director of Investigations & Operational Performance to strengthen investigation excellence, CAPA effectiveness, and state of inspection readiness across the site. This leadership role partners with Quality, Manufacturing Operations, Logistics, and Strategy to drive systemic improvements.

The role requires a technical degree and 10+ years in biopharma/quality/operational excellence with GMP experience, and a proven record in leading

Qualifications

  • Bachelor's degree in a technical discipline required.
  • 10+ years biopharmaceutical, manufacturing, quality, or operational excellence experience preferred.
  • Experience leading investigations, CAPA, root cause analysis, or operational improvement in GMP environment.

Responsibilities

  • Own and improve investigations across the site to drive learning and systemic improvement.
  • Lead complex, cross-functional investigations and systemic problem-solving efforts.
  • Lead CAPA effectiveness to address systemic issues and reduce risk.
  • Partner with operations, quality, and strategy teams to improve reliability and performance.
  • Build capability in investigation excellence, root cause analysis, and standardized practices.
  • Own site governance processes including Investigation Reviews and CAPA Effectiveness Reviews.
  • Use data and trends to identify opportunities for performance improvement and risk reduction.
  • Lead the site's continuous Inspection Readiness program with QA alignment.
  • Translate regulatory intelligence and inspection trends into proactive readiness actions.
  • Develop site-wide inspection capability through assessments and simulations.
  • Lead a high-performing team serving as trusted investigators and change agents.

Skills

Investigations leadership
CAPA management
Root cause analysis
Quality systems
Regulatory compliance
Change management

Education

Bachelor's degree in a technical discipline

Job description

Moderna Therapeutics in Norwood, MA seeks an Associate Director of Investigations & Operational Performance to strengthen investigation excellence, CAPA effectiveness, and state of inspection readiness across the site. This leadership role partners with Quality, Manufacturing Operations, Logistics, and Strategy to drive systemic improvements.

The role requires a technical degree and 10+ years in biopharma/quality/operational excellence with GMP experience, and a proven record in leading

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