External Quality Manager – Contract Labs (ECL)

Regulatory Jobs; Horsham, Malvern, Raritan (PA, Chester County, NJ); On-site; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, External Quality for External Contract Laboratories (ECL) Americas, based in Horsham, PA or nearby locations. You will lead QA/QC oversight of external labs, drive audits, and ensure cGMP compliance across NA and LATAM regions.

The role requires 6+ years in regulated pharma/biotech environments, 2+ years in QA/QC or analytical development, and strong collaboration with global teams. International travel up to 20% may be required.

Qualifications

• Bachelor’s or equivalent degree is required; focus in Engineering, Science or technical discipline preferred.
• 6+ years of experience in Pharmaceutical, Medical Device or Biotech regulated environment (e.g. FDA).
• 2+ years of experience in Pharma Quality Control or Analytical Development laboratories or closely related experience.
• Extensive experience in Quality Assurance, Quality Control and/or Compliance.
• Knowledge of FDA/EMA regulatory requirements applicable to biologics and/or pharmaceuticals’ testing.
• Ability to independently manage work to meet project objectives and timelines.
• Ability to work within multiple cross functional teams with global composition.
• Strong interpersonal and written/oral communication skills.
• Experience in using Pharmaceutical QMS systems.
• Auditing experience.
• Ability to build relationships with suppliers who support J&J.

Responsibilities

• Lead QA/QC oversight of External Contract Labs (ECLs) globally.
• Coordinate audits, corrective action plans and remediation with ECLs.
• Develop and maintain Quality Agreements with External Contract Labs.
• Monitor deviations, CAPAs and QC metrics to ensure timely release.
• Support cGMP compliance and regulatory requirements.
• Travel up to 20% for site audits and oversight.

Skills

Communication skills

Cross-functional collaboration

English proficiency

Negotiation skills

Timelines management

Education

Bachelor’s degree or equivalent

Tools

QMS systems

Auditing experience

Job description

Johnson & Johnson is seeking a Manager, External Quality for External Contract Laboratories (ECL) Americas, based in Horsham, PA or nearby locations. You will lead QA/QC oversight of external labs, drive audits, and ensure cGMP compliance across NA and LATAM regions.

The role requires 6+ years in regulated pharma/biotech environments, 2+ years in QA/QC or analytical development, and strong collaboration with global teams. International travel up to 20% may be required.