Principal Product Quality Leader

Primary Responsibilities Include The Following

• Provide effective, cross-functional quality leadership, and support program deliverables for late phase and commercial programs
• Author and revise annual reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author regulatory filing sections and RTQs
• Conduct science and risk-based evaluation of complex process and product quality data
• Communicate effectively with oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies
• Extract and analyze data from various sources and Quality systems
• Demonstrate proficiency in knowledge of cGMP and international regulatory expectations

Qualifications

• PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field
• 10+ years of experience in pharmaceutical product quality, preferably in a regulated environment
• Experience with cGMP and international regulatory requirements
• Strong scientific background with a focus on product quality and process improvement
• Excellent communication skills, both written and verbal
• Ability to work independently and as part of a team

Skills

• Strong understanding of cGMP and international regulatory expectations
• Experience with product quality risk assessment and compliance
• Proficiency in data analysis and interpretation
• Excellent organizational and problem-solving skills
• Ability to communicate complex information clearly and concisely

Benefits

• Competitive compensation package
• Flexible working hours
• Professional development opportunities
• Health and wellness benefits
• Employee recognition and rewards program

Pay

Target PR Range: 53-63/hr DOE

Schedule

Full-time