QC Project Lead – GMP & Regulatory Compliance

Bachem; Vista (CA); On-site; USD 98,000 - 135,000; Full time

Benefits offered by this job

Annual performance bonus

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation

Job summary

Bachem Americas is seeking a QC Project Lead to manage all Quality Control project activities, acting as the primary contact among QC teams, cross-functional departments, leadership, and external clients. You will oversee planning, resources, risk, and timelines to ensure compliant, efficient project delivery.

The role requires GMP experience, GC/HPLC/KF proficiency, and strong leadership to drive continuous improvement and KPI-focused performance. Torrance-site testing is a key component.

Qualifications

• Bachelor's degree in chemistry or related life sciences field.
• 5+ years' QC experience in biotech/pharma.
• 3+ years' experience in biotech/pharma CDMO setting.
• 4+ years of project management in a GMP environment (preferred).
• Experience with analytical techniques/instruments: GC, HPLC, KF, etc.
• Excellent presentation skills.
• Ability to coordinate and maintain contracted vendor services.

Responsibilities

• Manage customer projects and serve as the primary QC point of contact for project-related activities, ensuring timely execution and compliance with GMP/regulatory requirements.
• Oversee critical testing activities at the Torrance site, including stability studies and regulatory-driven testing.
• Support leadership in project prioritization, resource planning, and allocation for QC activities and deliverables.
• Coordinate testing activities between Bachem sites to support timely product/service delivery and meet weekly targets.
• Lead cross-functional resolution of testing issues at contract sites, including deviations and investigations, with timely escalation and risk assessment.
• Lead communications with RA, QA, Project Management, and stakeholders on stability issues, data trends, and regulatory inquiries; ensure timely resolution.
• Lead authoring/review/approval of project protocols, reports, and documentation with regulatory compliance.
• Contribute to continuous improvement and KPI monitoring in QC laboratory to drive efficiency and compliance.

Skills

GC / HPLC / KF

Presentation skills

Vendor management

GMP/regulatory compliance

Education

Bachelor's degree in chemistry or related life sciences

Tools

Gas Chromatography

High Performance Liquid Chromatography

Karl Fischer

Job description

Bachem Americas is seeking a QC Project Lead to manage all Quality Control project activities, acting as the primary contact among QC teams, cross-functional departments, leadership, and external clients. You will oversee planning, resources, risk, and timelines to ensure compliant, efficient project delivery.

The role requires GMP experience, GC/HPLC/KF proficiency, and strong leadership to drive continuous improvement and KPI-focused performance. Torrance-site testing is a key component.