Senior QC Project Lead - Global Biopharma

Boehringer Ingelheim; Fremont (CA); Sur place; USD 128 000 - 192 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision coverage

Retirement savings opportunities

Paid time off

Disability and life insurance

Résumé du poste

Boehringer Ingelheim is seeking a Principal Specialist in Quality Control Project Management to oversee QC deliverables on complex biotechnological projects for BI's captive use and contract manufacturing. The role involves planning, monitoring, and reporting while coordinating with global partners and customers.

You will interact with operations, international PM, process science, supply chain, engineering and BI Innovation to ensure high-quality analytics, MSO ownership, and compliance with

Qualifications

• Bachelor’s Degree in Science with 7+ years pharma experience.
• Master’s Degree with 5+ years or PhD with 2+ years considered.
• Strong knowledge of biopharmaceutical production processes.
• Global team experience required.
• Project management skills and project management systems required.
• Excellent communication and leadership abilities.

Responsabilités

• Define work packages according to project scope with the CMC Project Leader; act as primary QC member for external clients or BI IU team.
• Guide the analytical sub-team on contractual aspects (CROs) and ensure information flow within QC.
• Support the implementation of QC standards at BI Fremont including specifications, sampling, methodologies, transfer and validation.
• Contribute to global BI standards and lead/change management initiatives.
• Local MSO for core QC processes (e.g., OOX and stability).
• Coordinate outsourcing of project analytics and review data from contract labs.

Connaissances

Project Management

Cross-functional Collaboration

Leadership

Regulatory Knowledge

Formation

Bachelor's Degree in Science

Master’s Degree

PhD (considered)

Outils

Quality Systems (Deviations, CAPA, Change Control)

Description du poste

Boehringer Ingelheim is seeking a Principal Specialist in Quality Control Project Management to oversee QC deliverables on complex biotechnological projects for BI's captive use and contract manufacturing. The role involves planning, monitoring, and reporting while coordinating with global partners and customers.

You will interact with operations, international PM, process science, supply chain, engineering and BI Innovation to ensure high-quality analytics, MSO ownership, and compliance with