R&D QUALITY STRATEGY LEAD

Investigo; Billerica (MA); Hybride; USD 160 000 - 195 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality Assurance

GCP Knowledge

Stakeholder Influence

Regulatory Understanding

Quality Metrics

Formation

Bachelor's in science or QA

Outils

Quality Management System

Description du poste

Compensation: $160K ~$195K base + 20% bonus + LTI eligibility

A global biopharmaceutical organization is looking for an experienced R&D Quality professional to serve as a strategic quality partner across development programs.

This is a senior-level role focused on bringing quality strategy, risk management, compliance, and inspection readiness into the drug development process. The position will partner closely with Clinical Development, Data Management, Biostatistics, Regulatory Affairs, and other R&D functions while working with senior stakeholders and external partners.

WHAT YOU'LL DO

• Develop and implement quality strategies for assigned development programs.
• Provide quality leadership and guidance throughout the product development lifecycle.
• Identify emerging quality risks, gaps, and trends and drive appropriate mitigation strategies.
• Lead or oversee risk assessments, audit strategy, and other quality activities.
• Support deviation investigations, root cause analysis, CAPA, and significant compliance issues.
• Lead inspection-readiness activities and support health authority inspections from preparation through closeout.
• Partner with clinical development, data management, biostatistics, regulatory affairs, vendors, and investigational sites.
• Provide quality insight and compliance metrics to support strategic decision-making.
• Support due diligence and other key business decisions from a quality perspective.
• Drive continuous improvement, quality-by-design, and consistent quality practices across development programs.
• Help strengthen quality procedures, guidance, audit tools, and clinical trial oversight practices.

WHAT WE'RE LOOKING FOR

• Bachelor's degree in a scientific or quality-related discipline required; advanced degree preferred.
• 10+ years of experience in Quality Assurance or a related pharmaceutical/biotechnology environment.
• Strong experience with GCP and global clinical development requirements.
• Demonstrated understanding of drug development and clinical trial processes.
• Experience with quality risk management, audits, inspection readiness, root cause analysis, and CAPA.
• Ability to operate strategically and influence senior stakeholders in a matrixed organization.
• Strong communication and stakeholder-management skills.
• Experience working across multiple GxP areas or global development programs is highly valued.

The strongest candidates will come from R&D Quality, Clinical Quality, Clinical QA, GCP Quality, or related quality leadership backgrounds within pharmaceutical or biotechnology organizations.

This is a hybrid role requiring three days onsite each week in Billerica, MA.