Senior QC Project Lead – Global Biotech

Boehringer Ingelheim GmbH; Fremont (CA); Híbrido; USD 128.000 - 192.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical coverage

Dental coverage

Vision coverage

Retirement savings

Paid time off

Paid holidays

Disability insurance

Life insurance

Descripción de la vacante

Boehringer Ingelheim in Fremont, CA is seeking a Principal Specialist in QC Project Management to lead QC deliverables for complex biotech projects geared toward captive use and contract manufacturing. You will plan, monitor, and report QC activities collaborating with global partners and internal teams.

The role requires ensuring compliance with FDA/ICH guidelines, contributing to MSO ownership, and driving continuous process improvements within a highly regulated environment.

Formación

• Bachelor’s or higher degree in Science with relevant pharmaceutical industry experience.
• Proven project management experience in a regulated biopharma environment.
• Strong communication, leadership, and cross-functional coordination skills.
• Experience with regulatory inspections and quality systems is preferred.

Responsabilidades

• Define and manage QC deliverables for biotechnological projects.
• Coordinate cross-functional teams across QA, QC, and operations.
• Oversee OOS, stability processes, and MSO ownership.
• Represent QC in audits, inspections, and client interactions.
• Develop and implement project management systems and dashboards.

Conocimientos

Project management

Cross-functional collaboration

Strategic thinking

Leadership

Communication skills

Problem-solving

Biopharmaceutical knowledge

Regulatory knowledge

Educación

Bachelor’s Degree in Science

Master’s Degree in Science

PhD in Science

Descripción del empleo

Boehringer Ingelheim in Fremont, CA is seeking a Principal Specialist in QC Project Management to lead QC deliverables for complex biotech projects geared toward captive use and contract manufacturing. You will plan, monitor, and report QC activities collaborating with global partners and internal teams.

The role requires ensuring compliance with FDA/ICH guidelines, contributing to MSO ownership, and driving continuous process improvements within a highly regulated environment.