Senior QC Project Lead – Global Biopharma

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

Ventajas ofrecidas por este puesto de trabajo

Relocation assistance

Discretionary bonus

Medical insurance

Paid time off

Descripción de la vacante

Boehringer Ingelheim Fremont is seeking a Principal Specialist in QC Project Management to oversee QC deliverables on complex biopharma projects. The role involves planning, controlling, monitoring and reporting, with global partners and client interactions.

The candidate will lead cross-functional teams, manage MSO for OOS and stability processes, and support inspections while driving continuous improvement in QC project management. Requires strong leadership and regulatory familiarity.

Formación

• Bachelor’s Degree in Science with 7+ years pharma experience.
• Master’s degree with 5+ years or PhD with 2+ years pharma experience will be considered.
• Strong knowledge of biopharmaceutical production processes.
• Experience working on global teams is required.
• Project management skills and systems experience are required.
• Excellent communication and leadership in cross-functional, global environments.

Responsabilidades

• Define work packages with the CMC Project Leader and coordinate with clients.
• Lead analytical sub-team and ensure timely project updates to cross-functional teams.
• Support QC project standards: specifications, sampling, method transfer and validation.
• Contribute to global BI standards and local implementation; manage change initiatives.
• Local MSO for OOX and stability processes.
• Oversee outsourcing of project analytics and review data from contract labs.
• Establish project management systems, dashboards and reports.
• Represent BI policies in inspections, audits, and client meetings.

Conocimientos

Project management

Cross-functional leadership

Regulatory knowledge

Analytical thinking

Communication skills

Problem solving

Strategic thinking

Leadership

Educación

Bachelor’s Degree in Science (Biology, Chemistry, Biotech, Pharma or equivalent)

Master’s degree with 5+ years or PhD with 2+ years pharma experience

Descripción del empleo

Boehringer Ingelheim Fremont is seeking a Principal Specialist in QC Project Management to oversee QC deliverables on complex biopharma projects. The role involves planning, controlling, monitoring and reporting, with global partners and client interactions.

The candidate will lead cross-functional teams, manage MSO for OOS and stability processes, and support inspections while driving continuous improvement in QC project management. Requires strong leadership and regulatory familiarity.