Site Quality & Compliance Lead - Training & CAPA Champion

Boehringer Ingelheim; United States; À distance; USD 140 000 - 190 000; Plein temps

Résumé du poste

Boehringer Ingelheim is seeking a Site Quality and Compliance Lead to drive quality and compliance across Phase I–IV trials and related programs in the US. You will develop training, monitor inspection readiness and lead CAPA activities in collaboration with Legal, CD&O and other functions.

The role emphasizes delivering high-quality project outcomes, maintaining regulatory standards, and partnering with cross-functional teams to ensure timely, compliant execution of clinical programs.

Qualifications

• Current knowledge of government regulations (FDA, ICH, GCP) and related SOPs.
• Bachelor's degree in life sciences or related field preferred.
• Strong attention to quality, ethics and regulatory compliance in clinical development.

Responsabilités

• Lead quality activities and inspection readiness for US/international trials.
• Develop and deliver training programs for US CDO organization.
• Coordinate quality reviews and CAPA activities with cross-functional teams.
• Act as primary contact for US CD&O non-compliances and drive resolutions.
• Report quality metrics and identify risk areas with mitigations.

Connaissances

Quality management

Regulatory compliance

Project management

Communication

Planning and organization

Teamwork and collaboration

Driving continuous improvement

Analytical thinking

Formation

Bachelor's Degree (Life sciences preferred)

Description du poste

Boehringer Ingelheim is seeking a Site Quality and Compliance Lead to drive quality and compliance across Phase I–IV trials and related programs in the US. You will develop training, monitor inspection readiness and lead CAPA activities in collaboration with Legal, CD&O and other functions.

The role emphasizes delivering high-quality project outcomes, maintaining regulatory standards, and partnering with cross-functional teams to ensure timely, compliant execution of clinical programs.