Product Quality Specialist – Stability

About the role

The Product Quality Specialist will join the Stability Center of Excellence (CoE) within Johnson & Johnson Innovative Medicine. You will be responsible for end‑to‑end stability management of API and drug product families from late‑stage development through full commercialization.

Key responsibilities

• Act as the stability point of contact for assigned product families.
• Oversee sample management and ensure proper storage and handling.
• Author and review stability protocols and reports in line with global SOPs.
• Support audits, regulatory filings, temperature excursions, change controls and stability notifications.
• Maintain up‑to‑date stability statements for each product.
• Collaborate with Stability Labs to resolve technical questions promptly.
• Contribute to Stability CoE goals and continuous‑improvement initiatives.

Required profile

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Biochemistry, Engineering or a related scientific field.
• Experience in pharmaceutical stability testing and quality assurance.
• Strong understanding of GMP, SOPs and regulatory requirements.
• Ability to work cross‑functionally with PQI/PQO and business partners.

Required skills

• Stability testing
• GMP compliance
• Standard Operating Procedures (SOP) management

What we offer

• Opportunity to work on innovative medicines that impact global health.
• Inclusive and diverse work environment.
• Access to professional development resources within a leading multinational.