Senior Manager, Quality Systems and Compliance

JCW Group; Philadelphia (Philadelphia County); On-site; USD 130,000 - 190,000; Full time

Job summary

JCW Group in the Greater Philadelphia area seeks a Senior Manager of Quality Systems and Compliance to lead the site’s quality framework for drug product manufacturing. This is a permanent, onsite role focused on building robust systems and regulatory readiness.

You will own the site’s quality systems, drive a transformation with emphasis on inspection readiness, internal audits, and continuous compliance improvements.

Qualifications

• 12+ years in pharma QA with 5+ years in people management.
• Experience with CAPA, deviations, change control, complaints, and supplier quality.
• Drug product experience, ideally oral solid dose.
• CDMO or DEA/controlled substances experience is a plus.

Responsibilities

• Own site quality systems and drive a quality transformation, with a focus on inspection readiness, internal audits and compliance improvement.
• Lead quality assurance activities to ensure ongoing regulatory readiness and robust supplier quality management.

Skills

QA leadership

CAPA management

Deviations handling

Change control

Audit management

Job description

Senior Manager, Quality Systems and Compliance | Greater Philadelphia

I’m working with a global CDMO that’s hiring a Senior Manager of Quality Systems and Compliance for its drug product manufacturing site in the Greater Philadelphia area.

This is a permanent, fully onsite role. You’ll own the site’s quality systems and help drive a quality transformation, with a focus on inspection readiness, internal audits and compliance improvement.

You should apply if you have:

• 12+ years in pharma QA, including 5+ years leading people
• Experience managing CAPA, deviations, change control, complaints and supplier quality
• Drug product experience, ideally oral solid dose
• CDMO or DEA/controlled substance experience is a big plus