QMS & Compliance Technology Leader (Hybrid Biotech)

Avalo Therapeutics; Chesterbrook (PA); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Avalo Therapeutics is seeking a Sr. Manager, Quality Systems & Compliance Technology in Chesterbrook, PA. The role leads eQMS governance, CSV, and compliance across GMP/GCP/GDP environments to support clinical, CMC, regulatory, and partner activities.

You will supervise QMS platforms, drive continuous improvement, and partner with QA, IT, and Regulatory to ensure inspection readiness in a fast-paced biotech setting.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field required.
• 7+ years of QA experience in biotech/pharma setting preferred.
• Proven experience managing electronic QMS platforms (Veeva preferred).
• Strong knowledge of FDA/EMA/GxP data integrity expectations.

Responsibilities

• Provide strategic ownership and oversight of enterprise Quality Systems governance.
• Lead QMS administration, configuration, and lifecycle management of eQMS platforms.
• Drive CSV activities for regulated GxP systems and ensure inspection readiness.
• Support internal/external audits and regulatory inspections with documentation.
• Collaborate with IT, QA, Regulatory, and Ops to ensure compliant systems.

Skills

Quality Systems Governance

QMS Administration

CSV (Computer System Validation)

GxP Compliance

Vendor Management

Regulatory Inspections

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

Veeva

Job description

Avalo Therapeutics is seeking a Sr. Manager, Quality Systems & Compliance Technology in Chesterbrook, PA. The role leads eQMS governance, CSV, and compliance across GMP/GCP/GDP environments to support clinical, CMC, regulatory, and partner activities.

You will supervise QMS platforms, drive continuous improvement, and partner with QA, IT, and Regulatory to ensure inspection readiness in a fast-paced biotech setting.