Senior Specialist External Quality

About the role

Johnson & Johnson's External Quality team manages quality and risk for its Synthetic drug products made at external manufacturing sites. This Senior Specialist role works closely with the External Quality Site Lead to keep quality and compliance standards high, covering drug products, drug substances, packaging, testing, release, stability and supply. The role is open across several countries (Belgium, Italy, Switzerland) and may be posted under different requisition numbers.

Key responsibilities

• Support and oversee quality for external synthetic manufacturing, including commercial manufacturing, packaging, testing, release, stability and supply.
• Review and approve deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements.
• Monitor quality and compliance performance of external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history and supplier performance data.
• Identify and escalate quality, compliance or supply risks and support risk-based mitigation and remediation plans.
• Support qualification, ongoing monitoring and lifecycle management of external manufacturers and partners.
• Collaborate with Site Leads, Product Quality, MSAT, Planning, Procurement, Regulatory, EHS and qualified persons to meet registered requirements and patient supply needs.
• Support external manufacturers during J&J audits, health authority inspections and regulatory commitments, including preparation, response review and follow-up of agreed actions.
• Take part in technology transfer, new product introduction, product lifecycle management, process improvement and risk management for Synthetic products.

Required profile

• 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, preferably supporting external manufacturing, drug product or drug substance, packaging, testing, release or commercial supply.
• Working knowledge of cGMP, ICH requirements, quality systems and health authority expectations.
• Ability to review quality records, support root cause analysis and CAPA, and to work independently with minimal supervision.
• Excellent verbal and written communication skills and computer proficiency, including Microsoft Office.
• Up to 25% domestic and international travel may be required.

Preferred qualifications

• Experience with external manufacturers, contract manufacturing organizations, external contract laboratories or strategic partners.
• Cross-functional project team experience.
• Product transfer, new product introduction, parenteral and/or combination product experience.