Quality Control Project Manager

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

A Brief Overview

Responsible for leading and managing all Quality Control project activities, serving as the primary point of contact between QC teams, cross-functional departments, senior leadership, and external clients. Oversees project planning, execution, resource allocation, risk management, and timeline adherence to ensure successful project delivery. Ensures QC testing activities are completed in compliance with regulatory requirements, GMP standards, and company procedures while driving operational efficiency, strategic communication, and continuous improvement initiatives. Provides leadership and direction to project teams to support organizational objectives and client expectations.

A Brief Overview

Responsible for leading and managing all Quality Control project activities, serving as the primary point of contact between QC teams, cross-functional departments, senior leadership, and external clients. Oversees project planning, execution, resource allocation, risk management, and timeline adherence to ensure successful project delivery. Ensures QC testing activities are completed in compliance with regulatory requirements, GMP standards, and company procedures while driving operational efficiency, strategic communication, and continuous improvement initiatives. Provides leadership and direction to project teams to support organizational objectives and client expectations.

What You Will Do

• Manage customer projects and serve as the primary Quality Control point of contact for project-related activities, ensuring timely execution, cross-functional coordination, and compliance with GMP and regulatory requirements.
• Oversee critical testing activities at the Torrance site, including stability studies and other regulatory-driven testing requirements.
• Support departmental leadership in project prioritization, resource planning, and allocation to ensure efficient execution of QC activities and project deliverables.
• Coordinate testing activities between Bachem sites to support timely product and service delivery while contributing to achievement of weekly operational and financial targets.
• Lead cross-functional resolution of testing issues at contract sites, including deviations and laboratory investigations, ensuring timely escalation, risk assessment, and effective resolution in alignment with quality and regulatory expectations.
• Lead customer communications with RA, QA, Project Management, and other stakeholders on stability issues, data trends, specification setting, and regulatory inquiries, ensuring clear escalation, alignment, and timely resolution of quality-related matters.
• Lead the authoring, review, and approval of project-related protocols, reports, and associated technical documentation, ensuring scientific accuracy, regulatory compliance, and alignment with GMP requirements.
• Lead and actively contribute to continuous improvement initiatives within the QC laboratory, including development and monitoring of KPIs to drive operational efficiency, compliance, and performance excellence.

Qualifications

• Bachelor's degree in chemistry or a related life sciences field
• 5+ years' QC experience in biotech/pharma
• 3+ years' experience in a biotech/pharma CDMO setting
• 4+ years of project management experience in a GMP environment (preferred)
• Extensive experience with the use of analytical techniques/ instruments, including Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), Karl Fischer (KF), etc.
• Excellent presentation skills
• Ability to coordinate and maintain contracted vendor services and work assignments.

Base Annual Salary Range: $98,408 - $135,311

Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training.

Total Rewards

• Competitive pay
• Annual performance bonus
• Generous benefit package with comprehensive Medical/Dental/Vision coverage
• 401(k) plan with employer contribution
• Paid vacation, personal and sick days

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.