Manager GMP Quality Operations

Responsibilities

• Provide QA support for Cell and Gene Therapy manufacturing operations across all development phases.
• Oversee Quality Systems across CDMOs, focusing on compliance, CAPA effectiveness, change control, and risk management.
• Develop and maintain quality metrics, dashboards, and reports using Python, Power BI, and Smartsheet.
• Design and implement AI-enabled digital solutions for backlog triage, records reconciliation, and archiving to improve operational efficiency.
• Identify compliance risks in GMP processes and support the implementation of mitigating controls.
• Support audit and inspection readiness activities and lead continuous improvement projects.

Requirements

• Bachelor's degree in a Business or Sciences field.
• 5+ years of QA experience in a GMP-regulated environment.
• Demonstrated ability to design and deliver digital or AI-driven solutions to improve quality operations.
• Experience providing QA support to GMP manufacturing operations.
• Proficiency with network-based applications such as Oracle, TrackWise, or Veeva.
• Strong problem-solving skills with the ability to make decisions using a risk-based approach.

Preferred Qualifications

• Hands-on experience with ATMPs (cell therapy, gene therapy, tissue-engineered products) or Biologicals/sterile products.
• Experience developing intelligent digitized solutions for lifecycle management of GMP records.

Benefits

• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the Summer and Winter.
• Educational assistance programs, including student loan repayment.
• 401(k) with company matching.
• Annual bonus and annual equity awards.

About the Company

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company is dedicated to advancing clinical and research programs in areas such as cystic fibrosis, sickle cell disease, and other serious genetic diseases.