Product Quality Specialist

• Serve as stability point of contact for assigned API and drug product families
• Oversee stability sample management
• Author and oversee stability protocols and reports in accordance with global SOPs, including sampling strategy
• Support audits and regulatory filings related to stability questions
• Manage stability lifecycle activities
• Support PQI/PQO and business partners with stability‑related questions
• Support temperature excursions, change controls, stability notifications, and escalations
• Maintain stability statements for assigned products
• Partner with Stability Labs to address questions promptly
• Support Stability CoE departmental goals and continuous improvement
• Contribute input during staff meetings to improve stability processes

• Bachelor’s degree required, majoring in Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific discipline
• Minimum 6 years of relevant experience required
• Minimum 4 years of experience in the pharmaceutical, biotechnology, or medical device industry required
  
  Postgraduate experience and/or education counts toward years of industry experience
• Experience in API and drug product stability and business implications of stability decisions desired
• Understanding of quality processes and systems, including change control, event handling, CAPA, and risk management required
• Insight into pharmaceutical and/or chemical processes, product quality assurance/control, and product development and manufacturing is a plus
• Ability to work independently and in a team environment
• Relationship building as part of a team required
• Strong written and oral communication skills with various organizational levels
• Understanding of global regulatory requirements and guidelines applicable to pharmaceuticals, with ability to apply GMP regulations
• Flexibility to accommodate US, EMEA, and AP work schedules when vital
• Willingness to travel 5–10% domestically and internationally

Demonstrates expertise in API and drug product stability management, including protocol authoring and regulatory compliance. Proficient in quality processes such as change control and risk management, with strong communication and relationship‑building skills.

• API Stability Management
• Regulatory Compliance
• Quality Processes
• Pharmaceutical Industry Experience
• Communication Skills

• Stability Sample Management
• Stability Protocol Authoring
• Change Control
• CAPA
• Risk Management
• Pharmaceutical Processes
• Product Quality Assurance
• Product Development
• GMP Regulations
• Temperature Excursion Management

• Team Collaboration
• Relationship Building
• Independent Work
• Written Communication
• Oral Communication

• Pharmaceutical Industry
• Biotechnology
• Medical Device Industry
• Global SOPs
• Stability Lifecycle Activities
• Stability Notifications
• Continuous Improvement
• Stability CoE
• Audits
• Regulatory Filings