Senior External Quality Specialist – Drug Product & Supply

Johnson & Johnson Co.; Allschwil; On-site; CHF 90,000 - 130,000; Full time

Benefits offered by this job

Travel up to 25%

Job summary

Johnson & Johnson seeks a Senior Quality Specialist to support external manufacturing and ensure cGMP compliance for drug products and substances. You will partner with External Quality, MSAT, Regulatory and manufacturing teams to uphold product quality and patient supply.

The role requires QA oversight, CAPA management, and collaboration across sites, with travel up to 25% to support audits and manufacturing activities.

Qualifications

• Bachelor’s degree or equivalent in Pharmacy, Science, Engineering or related technical discipline.
• Experience in quality management in GMP-regulated environments.
• Experience with external manufacturing, drug product/substance, packaging, testing or release.

Responsibilities

• Provide QA support and oversight for external Synthetics manufacturing operations and related supply activities.
• Review deviations, non-conformances, investigations, CAPAs, change controls and batch records.
• Monitor supplier performance using quality metrics and audit histories.
• Identify and escalate quality or supply risks with mitigation plans.
• Support lifecycle management of external manufacturers and strategic partners.
• Collaborate with cross-functional teams to meet patient supply needs and regulatory commitments.

Skills

Quality Assurance

Regulatory Compliance

CAPA & Change Control

Risk Management

Communication

Problem Solving

Education

Bachelor's degree in Pharmacy, Science, Engineering

Tools

Microsoft Office

QMS Tools

Job description

Johnson & Johnson seeks a Senior Quality Specialist to support external manufacturing and ensure cGMP compliance for drug products and substances. You will partner with External Quality, MSAT, Regulatory and manufacturing teams to uphold product quality and patient supply.

The role requires QA oversight, CAPA management, and collaboration across sites, with travel up to 25% to support audits and manufacturing activities.