Alexza Pharmaceuticals is a specialty pharmaceutical company located in Mountain View, California, focused on the research, development and commercialization of novel proprietary products for the acute treatment of central nervous system conditions. Our product candidates are based on our proprietary technology, the Staccato® system. The Staccato system vaporizes an excipient-free drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery. Our first product, Staccato loxapine, (known commercially as ADASUVE®) has been approved for marketing in the United States by the U.S. Food and Drug Administration and in the European Union by the European Commission. We also have a pipeline of product candidates based on the Staccato system which are in various stages of development for acute and intermittent conditions, for which we believe the Staccato platform is particularly applicable.
As a member of the Alexza Pharmaceuticals Quality Systems team, the Lead Quality Auditor improves quality and regulatory compliance through the planning, execution and follow-up of a comprehensive review program. Further, this role provides internal consulting and leadership to advise internal departments on best practices. Finally, the individual in this role will track and trend industry-wide audit observations and stay active in the industry to identify evolving regulatory actions.
• Lead the Internal Audit Function
o Develop, maintain, and execute the internal audit schedule
o Evaluate audit responses for adequacy and acceptability
o Monitor and drive for completion of corrective actions to minimize risk and compliance exposure
o Maintain, report and advocate improvement of internal audit metrics
o Maintain and improve internal audit procedures and work standards
• Responsible for Quality System Governance activities, which would include but not be limited to:
o Facilitate the completion of any audit-related corrective action plans
o Development and maintenance of Quality System metrics that assure a high level of global compliance is maintained
o Lead inspection readiness project teams, as required
o Lead inspection teams
• Monitor changes to applicable regulations, industry trends and/or regulatory guidance
• Identify the impact of regulatory changes against Alexza’s Quality System. Collaborate with process owners to make required procedural recommendations
• Assist with training of Subject Matter Experts in preparation for regulatory body inspections
• Assist with the preparation of Management Reviews
• Assist and/or provide support as needed for Quality System improvement initiatives
• Demonstrated leadership and project management
• Knowledge and understanding of combination pharmaceutical/device product 21 CFR 3.2(e), CFR 210 / 211, CFR 820, European pharma regulations
• Knowledge of Electronic Records/Electronic Signature 21 CFR 11
• Working knowledge of industry guidelines including: ICH 10; understanding Pharmaceutical Quality Systems framework and ISO 13485.
• Able to provide GMP technical consulting and advice to internal departments
• Strong interpersonal skills
• Excellent written and verbal communication skills
• Strong strategic business perspective and systems thinking capability
• Ability to handle multiple priorities in a project driven environment
• Ability to work in a team environment and able to collaborate with others throughout the organization
• Ability to maintain a flexible, and thorough risk-based approach to problem-solving
• Ability to maintain detailed and accurate records
• Proficient in the use of a wide variety of computer applications including the MS office, Excel, and project management software
Education and Experience:
• BS/BA degree in a scientific discipline
• At least 8+ years quality system management experience in the combination pharmaceutical/medical device industry. At least 3 of those years leading Internal Audit. Preference for ASQ Certified Quality Auditor
• Successful leadership of at least 3 site inspections initiated by regulatory bodies
We offer competitive compensation and benefits including stock options, an exciting and collaborative work environment and excellent opportunity for career growth.
Alexza Pharmaceuticals is an Equal Opportunity Employer. Direct Applicants only - NO AGENCIES, PLEASE.