Global QC Project Lead — Biopharma

BoehringerPRD; Fremont (CA); On-site; USD 128,000 - 192,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Retirement savings opportunities

Paid time off & holidays

Disability and life insurance

Job summary

Boehringer Ingelheim is seeking a Principal Specialist in Quality Control (QC) Project Management to oversee QC deliverables on complex biopharma projects for captive use and CROs. You will plan, monitor and report QC activities, coordinating with global partners and customers.

The role interfaces with operations, international PM, process science, supply chain and BI Innovation. Strong MSO ownership for OOS and stability processes is required.

Qualifications

• Bachelor’s degree in Science with 7+ years in pharma.
• Advanced degree (MS/PhD) with minimum experience considered.
• Strong knowledge of biopharma production processes.
• Experience working on global teams and project management.

Responsibilities

• Define work packages with the project lead and coordinate QC with clients.
• Lead analytical sub-team and ensure timely project updates.
• Implement QC standards and validate methods and stability analytics.
• Contribute to global standards and lead change initiatives.
• Represent QC in inspections, audits and client meetings.
• Oversee project management systems, plans and dashboards.
• Ensure compliance with FDA/EMA/ICH guidelines.

Skills

Project management

Cross-functional leadership

Quality systems

Biopharma

Regulatory compliance

Analytical thinking

Communication

Global collaboration

Education

Bachelor’s Degree

Master’s Degree or PhD considered

Tools

Project Management Systems

Job description

Boehringer Ingelheim is seeking a Principal Specialist in Quality Control (QC) Project Management to oversee QC deliverables on complex biopharma projects for captive use and CROs. You will plan, monitor and report QC activities, coordinating with global partners and customers.

The role interfaces with operations, international PM, process science, supply chain and BI Innovation. Strong MSO ownership for OOS and stability processes is required.