Director, Quality Assurance

Alexza Pharmaceuticals   •  

Mountain View, CA

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 21 days ago

Responsibilities

  • Lead all Quality Assurance functions for both commercial and clinical products manufacturing and development
  • Responsible for staffing and management of department personnel
  • Lead the development, implementation and maintenance of quality systems and related activities to ensure compliance to applicable regulatory requirements (e.g., deviations/CAPA process, Change Control and documents management, Quality procedures, validation program, product complaints program, and selection, evaluation and oversight of suppliers and service providers
  • Lead effort to develop phase-appropriate Quality Systems
  • Lead CCB and MRB meetings
  • Schedule and participate in external and internal audits
  • Responsible for materials and product lot release
  • Serve as primary interface with Regulatory Agency inspectors during GMP inspections
  • Serve as primary interface on Quality Assurance matters with corporate partners and Ferrer Quality unit
  • Responsible for Quality Management Reviews
  • Responsible for Product Quality Review report
  • Responsible for development and management of departmental budget
  • Provides mentorship to staff

Skills required

  • Comprehensive knowledge of cGMP regulations (US and EU), Quality Systems, ISO, and SOPs applicable to pharmaceutical and/or medical device organizations
  • Excellent verbal and written communication skills
  • Strong leadership ability, both within department and in cross-functional team settings
  • Ability to exercise judgment within broadly defined practices and policies to evaluate and solve problems
  • Solid understanding of pharmaceutical and medical device development

Education and experience

  • BS in Life Sciences, Chemistry or related science disciplines
  • Minimum of 10 years Quality Assurance experience in pharmaceutical and/or medical device industry
  • Experience in drug/device combination products is a plus, and experience in inhalation products is highly desirable