VP, Quality Assurance - Northeast
Our client is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. The Company has five product candidates in clinical development and several others in preclinical development.
Qualifications:
• 10+years Quality Assurance experience in pharmaceutical or biotechnology industry.
• Experience in bringing a drug/biologic to market including NDA/BLA filing and pre-approval inspection.
• QA operations with strength in small molecules.
• Working knowledge of current Good Manufacturing Practices (CGMPs), quality systems, systems to assure compliance with international regulatory requirements and Chemistry, Manufacturing and Controls (CMC).
• Must possess sound understanding of pharmaceutical quality principles.
• Requires a strong CGMP compliance background and good regulatory understanding.
• Equipment/facility and process validation experience.
• Background in documentation review and control is a plus.
