Product Quality Specialist

About Johnson & Johnson Innovative Medicine

At Johnson & Johnson, we are committed to advancing health through meaningful healthcare innovation. Our Innovative Medicine division leverages patient insights to inspire science-driven developments, aiming to prevent, treat, and cure complex diseases with smarter, less invasive treatments. We foster a diverse, inclusive environment valuing each employee's individuality and integrity, reinforcing our commitment to responsible business practices worldwide.

Role Overview

The Product Quality Specialist within the Stability Center of Excellence (CoE) holds comprehensive responsibility for managing and overseeing stability activities for a range of products, spanning from Late Stage Development through full commercialization. This role demands expertise in protocol and report development focused on product stability and supports organizational quality initiatives to ensure seamless operations within the Stability CoE.

Key Responsibilities

• Serve as the primary point of contact for stability-related matters for assigned product families encompassing APIs and drug products.
• Oversee management of stability sample inventories to maintain data integrity.
• Develop, review, and manage stability study protocols and reports aligned with global standard operating procedures, incorporating appropriate sampling strategies.
• Provide support for regulatory audits and submissions concerning stability requirements and inquiries.
• Manage product stability throughout its lifecycle ensuring compliance and quality standards are met.
• Assist Product Quality Improvement (PQI), Product Quality Operations (PQO), and business partners with inquiries and issues related to product stability.
• Coordinate responses and manage processes related to temperature excursions, change controls, stability notifications, and escalations.
• Maintain current and accurate stability statements for assigned products.
• Collaborate with stability laboratories to address queries promptly and effectively.
• Actively participate in Stability CoE team functions, contributing to departmental objectives and process improvements.

Candidate Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or a related scientific or technical field is required.
• At least 6 years of relevant professional experience, including a minimum of 4 years in the pharmaceutical, biotechnology, or medical device sectors post-degree.
• Demonstrated experience with API and drug product stability and understanding of the impact of stability decisions on business outcomes is highly desirable.
• Solid knowledge of quality processes and systems such as change control, event handling, CAPA, and risk management is essential.
• Familiarity with pharmaceutical or chemical manufacturing processes, quality assurance/control, and product development is advantageous.
• Strong capability to work both independently and collaboratively within teams.
• Excellent relationship-building skills and effective communication across organizational levels.
• Understanding of global pharmaceutical regulatory requirements and GMP guidelines, with practical application experience.
• Willingness and flexibility to accommodate key time zones (US, EMEA, AP) and manage work-life balance effectively.
• Availability for occasional domestic and international travel up to 5-10% based on business needs.

Additional Information

This position may be available in multiple countries under different requisition numbers complying with local regulations. Applications submitted across locations will be treated as a single consolidated submission.

Benefits

Johnson & Johnson offers a competitive base salary complemented by an annual performance-based bonus or sales commissions depending on role and location. Additional benefits include paid vacation, parental leave of at least 12 weeks, bereavement, caregiver and volunteer leaves, wellness reimbursements, and comprehensive programs supporting financial, physical, and mental health. Eligible employees and dependents can participate in various insurance plans and partake in service anniversary and recognition awards. Note that benefits and compensation may vary by location and are subject to change.