Senior Manager, Analytical QC & Quality Assurance

Vertex Pharmaceuticals; Boston (MA); On-site; USD 124,000 - 145,000; Full time

Job summary

Vertex Pharmaceuticals, a leader in cell & gene therapy, seeks a Senior Manager QA for QC to oversee analytical quality across development and transfer activities. You will drive RCA/CAPA for OOS/OOT, review containment and change controls, and promote a data-driven, AI-enabled quality culture throughout the program lifecycle.

The role requires deep GXP knowledge, collaboration with internal and external labs, and leadership in continuous improvement. Up to 5% travel may be required.

Qualifications

• Bachelor's degree in a scientific or allied health field; graduate degree preferred.
• 8+ years in a regulated pharmaceutical environment.
• In-depth knowledge of GXP QA/QC across cell therapies.
• Experience with MES, LIMS, eQMS and data visualization tools.
• Experience leading internal labs and external testing partnerships.
• Strong project leadership in continuous improvement (LEAN, DMAIC, Six Sigma).
• Excellent communication and ability to influence quality culture.

Responsibilities

• Quality oversight of QC analytics and analytical development activities.
• Lead QA review and approval of development, qualification, validation and transfer.
• Ensure RCA and CAPA for OOS and OOT results.
• Review deviations, OOS, OOT and change controls.
• Demonstrate digital quality systems and AI concepts within GxP.
• Apply data analytics and AI-enabled solutions to improve quality oversight.
• Support QA risk management and mitigation planning.
• Contribute to Vertex quality systems, SOPs, policies and work instructions.
• Identify and drive continuous improvement initiatives.
• Develop quality metrics for contract organizations.

Skills

Subject matter expert

Regulatory QA

Data analytics

LEAN / SixSigma

Effective communication

Influencing quality culture

Education

Bachelor's in scientific field

Graduate degree preferred

Tools

MES

LIMS

eQMS

Data visualization tools

Job description

Vertex Pharmaceuticals, a leader in cell & gene therapy, seeks a Senior Manager QA for QC to oversee analytical quality across development and transfer activities. You will drive RCA/CAPA for OOS/OOT, review containment and change controls, and promote a data-driven, AI-enabled quality culture throughout the program lifecycle.

The role requires deep GXP knowledge, collaboration with internal and external labs, and leadership in continuous improvement. Up to 5% travel may be required.