Quality Systems Lead — CAPA & Compliance Champion

BioSpace; Raritan (NJ); On-site; USD 107,482 - 141,070; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company match

Paid parental leave

Paid time off including 15 vacation days

Flexible spending and health savings accounts

Short- and long-term disability coverage

Life and AD&D insurance

Job summary

A global biotechnology company in Raritan, NJ, is seeking a Quality Systems Lead to oversee compliance and quality processes within a cell therapy manufacturing facility. The ideal candidate has a Bachelor's degree in a relevant field, at least 4 years of experience, and a strong understanding of quality assurance in an aseptic manufacturing environment. Responsibilities include managing CAPA programs and driving improvements in quality systems. The position offers a competitive salary and benefits package.

Qualifications

• Minimum of 4 years of relevant work experience in quality assurance, manufacturing compliance, or clinical quality.
• Knowledge of GxP quality systems and relevant regulations.
• Ability to manage multiple projects in a fast-paced environment.

Responsibilities

• Provide oversight to the CAPA program for the CAR‑T manufacturing site.
• Oversee metrics, trending, and reporting of quality systems records.
• Drive continuous improvement of quality systems processes.

Skills

Analytical problem-solving

Communication skills

Attention to detail

Multitasking

Education

Bachelor’s Degree in Science or Engineering

Tools

Microsoft Office (Outlook, Excel, Word, PowerPoint)

Job description

A global biotechnology company in Raritan, NJ, is seeking a Quality Systems Lead to oversee compliance and quality processes within a cell therapy manufacturing facility. The ideal candidate has a Bachelor's degree in a relevant field, at least 4 years of experience, and a strong understanding of quality assurance in an aseptic manufacturing environment. Responsibilities include managing CAPA programs and driving improvements in quality systems. The position offers a competitive salary and benefits package.