Senior Specialist External Quality (Pharmaceutical Quality)

Location: Latina, Italy; Beerse, Belgium; or Allschwil, Switzerland. Up to 25% domestic and international travel may be required.

Company

Johnson & Johnson MedTech develops healthcare solutions through Innovative Medicine and MedTech.

What you will do

• Provide quality assurance oversight for external manufacturing, packaging, testing, release, stability, and supply activities for Synthetic drug products.
• Review and approve or provide quality concurrence for deviations, investigations, CAPAs, change controls, complaints, product disposition records, specifications, validation documents, and quality agreements.
• Monitor external manufacturer performance through quality metrics, risk ratings, audit outcomes, inspection history, supplier data, and issue trends.
• Identify and escalate quality, compliance, and supply risks while supporting risk-based mitigation and remediation plans.
• Support manufacturer qualification, lifecycle management, audits, health authority inspections, regulatory commitments, technology transfers, and new product introductions.
• Collaborate with Product Quality, MSAT, Planning, Procurement, Regulatory, EHS, Qualified Persons, site leads, and external partners.

Requirements

• Bachelor’s degree or equivalent in Pharmacy, Science, Engineering, or a related technical discipline.
• At least 4 years of experience in quality management, quality assurance, production, quality control, R&D, or a related pharmaceutical or biotechnology environment.
• Experience in a GMP-regulated environment and working knowledge of cGMP, ICH requirements, quality systems, and health authority expectations.
• Ability to assess quality records, identify gaps, support root cause analysis, and contribute to CAPA and risk-based decisions.
• Experience with deviations, CAPA, change controls, complaints, batch release, quality agreements, audits, or inspection support.
• Strong communication, organizational, independent working, prioritization, and Microsoft Office skills.

Nice to have

• Experience with external manufacturers, contract manufacturing organizations, contract laboratories, or strategic partners.
• Experience on cross-functional project teams, product transfers, new product introductions, parenteral products, or combination products.
• Knowledge of ISO 9001 and issue escalation practices.

Culture & Benefits

• Inclusive work environment focused on employee dignity, diversity, and individual contribution.
• Annual bonus based on pay grade, location, and company and employee performance.
• Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Recognition awards and access to insurance plans subject to local eligibility and plan terms.