Shift Quality Ops Lead - Cell Therapy

Vertex Pharmaceuticals Inc (US); Tallahassee (FL); On-site; USD 154,000 - 231,000; Full time

Job summary

Vertex Pharmaceuticals Inc. is seeking an Associate Director – Shift Quality Operations to provide on-site quality leadership for cell therapy manufacturing across assigned shifts.

You will ensure compliance with cGMP and aseptic processing requirements, support batch disposition, investigations, and line clearance, and lead a team of quality professionals on the shop floor. The role requires a Bachelor’s degree in a related field and 8+ years of experience in biotech quality, with strong

Qualifications

• Bachelor’s degree required in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related discipline.
• 8+ years in biotech/regulated pharma incl. aseptic manufacturing and quality control.
• Experience leading shift quality teams and ensuring inspection readiness.

Responsibilities

• Provide shift-based QA oversight for aseptic manufacturing, in compliance with cGMP and aseptic standards.
• Oversee degradation, investigations, and CAPA with timely closure in QMS.
• Lead and develop a team of shift quality professionals and ensure effective handoffs.
• Maintain ongoing inspection readiness and support audits and regulatory inspections.
• Collaborate cross-functionally with Manufacturing, QA, QC, MSAT, Engineering, Validation, and Supply Chain.

Skills

QA Oversight

cGMP

Aseptic Processing

Deviation Mgmt

CAPA

Data Analytics

Leadership

Risk Management

Regulatory Compliance

Education

Bachelor’s degree in Biotechnology/Related

Job description

Vertex Pharmaceuticals Inc. is seeking an Associate Director – Shift Quality Operations to provide on-site quality leadership for cell therapy manufacturing across assigned shifts.

You will ensure compliance with cGMP and aseptic processing requirements, support batch disposition, investigations, and line clearance, and lead a team of quality professionals on the shop floor. The role requires a Bachelor’s degree in a related field and 8+ years of experience in biotech quality, with strong