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.
This position will provide technical leadership and strategy for all aspects of quality systems and standards of the business. Areas of responsibilities may include but not limited to regulatory intelligence, change control, complaints, metrics and reporting, quality system standards, policies and procedures, compliance readiness, regulatory interface, documentation and control systems and other duties as assigned
• Direct, provide oversight and input into the relevant quality systems and standards areas including: deviation, CAPA, SCAR, change control; documentation systems; quality procedures, standards and policies; customer complaints; quality system reporting; and other related areas.
• Coordinating activities and leading interactions during regulatory agency inspections, notified third party audits, and customer audits.
• Provide direction and strategy to identify, assess, and remediate current and previous quality system risks, gaps, including conducting gap assessments and development of standards.
• Partner with various key stakeholders across the organization to assess all quality systems and standards needs and to provide resource and support for planning and execution.
• Significant cross functional collaboration with Quality Control, Manufacturing, R&D, Regulatory, Engineering, Supply Chain, and other related functions.
• Demonstrating leadership by ensuring the continual improvement of the Quality Systems.
• Providing leadership to and directing the daily activities of the Quality Systems and Standards Department.
• Ensuring management of changes associated with products and processes are carried out appropriately using science and risk-based assessment to determine the impact of change.
• Providing input and expertise into the supplier audit program, and supplier management.
• Ensuring key performance indicators measure progress against quality objectives.
• Monitoring, communicating, and acting on any emerging industry trends.
• Analyzing and exercising judgment on complex issues, guided by a thorough understanding of quality philosophy.
• Generation of Annual Product / Quality Reviews (APR/ PQR) in compliance with the requirement of GMP and International Regulations
• Establish and maintain a work environment focused on quality and that fosters learning, respect, open and effective communication, collaboration, and teamwork.
• Define, establish, and maintain departmental goals, objectives and key performance metrics
• Other duties as assigned.
• Excellent influencing and interpersonal skills, as well as the ability to influence and interact at multiple levels of the organization, manage multiple priorities, and deliver excellent results are required.
• Strong influencing and collaboration skills, and excellent written and verbal communications skills are required.
Ability to read, analyze, and interpret complex documents; Ability to respond effectively to sensitive inquiries or complaints; Clear and concise communication skills, both written and spoken; Ability to write technical reports and articles using original or innovative techniques or style; Ability to make effective and persuasive presentations on complex topics to top management, public groups, and/or boards of directors
• Reasoning Ability:
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems; Ability to deal with a variety of abstract and concrete variables; Ability to define problems, collect data, analyze and establish facts, draw conclusions and assess technical data for compliance with state acceptance criteria, and recommend solutions to complex problems related to quality control issues
Provide leadership to execute planning and operations operating under GXP, safety, and quality standards; Ability to interact professionally and effectively with peers, management and leadership both within and outside the department, within the company, and business partners.
Receive minimal guidance with respect to general objectives. In the majority of tasks and projects assigned, determine methods, work sequence, scheduling, and how to achieve objectives of assignments; Operate within specific policy guidelines. Manage and direct the selection, training, development, appraisal, and work assignments of laboratory personnel
Education and experience:
• Bachelor’s degree in quality or chemical engineering, microbiology, or equivalent field is desired. An MBA or technical MS degree is an asset. Preference will be given to candidates who have any the following certifications: Six Sigma Black Belt (SSBB); Certified Quality Engineer (CQE); Regulatory Affairs Certification (RAC); ISO RAB Certified Lead Auditor (RAB); Certified Pharmaceutical Industry Professional (CPIP).
• Minimum 8-10 years related experience.
• Proven experience with ISO13485 or equivalent quality standards is required.
• Proven experience interfacing with regulatory authorities, notified third party audits and either leading or being in a lead role during regulatory inspections.
• Must have experience or direct knowledge in several quality system elements (e.g. complaints, document change control, standards and systems management, quality directive and procedures, deviations, CAPA, SCAR, Annual and Product Quality Review APR/PQR, Compliance related field actions, alerts and like events).
• Experience working in a small to large scale cross-functional, matrixed environment is required.
• The ability to influence without authority is required. Process Excellence experience is required.
• Six Sigma Black Belt or related experience in Six Sigma, Design Excellence, Lean Thinking and Performance Dashboards is preferred. The ability to proactively identify improvement opportunities is required.
• A proven track record of participating in cross-functional teams to achieve significant quality and process improvements is required.
We offer competitive compensation and benefits including stock options, an exciting and collaborative work environment and excellent opportunity for career growth.
Direct Applicants only - NO AGENCIES, PLEASE.