Manager, Quality Control

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Vertex Manufacturing is seeking a Manager of Quality Control to oversee analytical functions across testing, reporting, and compliance with cGMP standards.

The role requires leadership of QC programs, data integrity, and collaboration with cross-functional teams to ensure timely, accurate results and continuous improvement.

Qualifications

• Bachelor's in science required; 8+ years in biopharmaceutical/industry QC management.
• Strong knowledge of analytical methods including flow cytometry, sterility, endotoxin, and cell culture.
• Knowledge of US/EU cGMP regulations and experience with regulatory inspections.

Responsibilities

• Oversee laboratory programs and QC analytical functions.
• Ensure timely execution of testing and data reporting.
• Coordinate sample management and data review across functions.
• Author and review data, SOPs and deviation investigations.
• Lead investigations and continuous improvement initiatives; drive quality impact.
• Serve as QC representative in cross-functional teams.

Skills

Analytical methods

QC management

cGMP

Education

Bachelor's in Science

Job description

Role

Manager, Quality Control, overseeing analytical functions at Vertex Manufacturing and Leiden Centers for testing, reporting, and cGMP compliance.

Responsibilities

• manage laboratory programs
• ensure timely execution
• coordinate sample management
• author/review data and SOPs
• lead investigations and continuous improvement initiatives
• serve as QC representative in cross-functional teams

Requirements

• Bachelor's in science with 8+ years in biopharmaceutical/industry QC management
• strong knowledge of analytical methods (flow cytometry, sterility, endotoxin, cell culture)
• US/EU cGMP regulations
• experience with regulatory inspections

Preferred qualifications

• prior QC management experience
• effective communication skills

High-Value

biological modalities supporting cell/gene therapies or biologics, night shift (Wednesday-Saturday, 9pm-9am), third shift role, on-site with flexible ad hoc options. No travel specified.

Collaboration

cross-departmental, vendor interactions, and quality investigations.