R&D Quality Strategy Lead — Hybrid (Senior)

Investigo

Billerica (MA)

Hybrid

USD 160,000 - 195,000

Full time

10 days ago

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Job summary

Investigo is seeking an experienced R&D Quality leader to serve as a strategic partner across development programs in the life sciences sector. This senior role focuses on quality strategy, risk management, compliance, and inspection readiness within drug development, collaborating with Clinical Development, Regulatory Affairs, Data Management, and external partners.

The ideal candidate has 10+ years in QA within pharma/biotech, deep GCP knowledge, and a proven ability to influence senior

Qualifications

Bachelor's degree in a scientific or quality-related discipline.
10+ years of experience in Quality Assurance within pharma/biotech.
Strong knowledge of GCP and global development requirements.
Experience with risk management, audits, inspection readiness and CAPA.
Ability to influence senior stakeholders in a matrixed org.

Responsibilities

Develop and implement quality strategies for development programs.
Provide leadership across product development lifecycle.
Identify quality risks and drive mitigation strategies.
Lead risk assessments, audits, and inspection readiness.
Support deviation investigations, CAPA, and compliance issues.
Lead inspection-readiness and support health authority inspections.
Partner with clinical development, data management, regulatory affairs, vendors, and sites.
Provide quality insights and metrics for strategic decisions.
Support due diligence from a quality perspective.
Drive continuous improvement and quality-by-design across programs.