Senior Director, Clinical Quality & Program Excellence

Regulatory Jobs; Massachusetts; A distancia; USD 154.000 - 243.000; Jornada completa

Descripción de la vacante

Regulatory Jobs in Massachusetts is seeking an experienced Quality Assurance leader to oversee global clinical research programs and ensure inspection readiness. You will serve as a strategic partner, guiding risk-based audit strategies and managing pre-approval inspections for sponsor and site activities.

The role requires 10+ years in pharma/biotech with 7+ years in GCP QA, strong writing and communication skills, and the ability to mitigate complex compliance risks across programs.

Formación

• Minimum of 10 years of experience in the pharmaceutical/biotech industry.
• Minimum 7 years in GCP-related Quality Assurance or clinical trial QA.
• Extensive knowledge of ICH GCP and global regulations for clinical development.
• Ability to translate audit findings into corrective actions and mitigations.
• Strong written communication and ability to influence in a matrix environment.

Responsabilidades

• Provide GCP compliance interpretation, consultation, training and recommendations.
• Lead program-specific risk-based audit and compliance strategy across sites.
• Manage audits of clinical delivery, documents, databases, vendors and systems.
• Lead investigations into quality issues and oversee corrective actions.
• Prepare for and support GCP health authority inspections and responses.
• Analyze metrics and communicate findings to teams and management.
• Escalate systemic problems and propose timely solutions.

Conocimientos

GCP compliance expertise

Auditing and investigations

Strong communication skills

Risk-based thinking

Quality system knowledge

Educación

BA/BS degree required

Advanced degree preferred

Descripción del empleo

Regulatory Jobs in Massachusetts is seeking an experienced Quality Assurance leader to oversee global clinical research programs and ensure inspection readiness. You will serve as a strategic partner, guiding risk-based audit strategies and managing pre-approval inspections for sponsor and site activities.

The role requires 10+ years in pharma/biotech with 7+ years in GCP QA, strong writing and communication skills, and the ability to mitigate complex compliance risks across programs.