Director, Quality Assurance (QA)

About the Company :

Our client is a leading venture backed pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Theirproducts are designed to deliver a drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner. This is a great opportunity to get introduced to a growing Bay Area Pharma company and learn new processes.

Job Description

Title : Director, Quality Assurance (QA)

Location : Mountain View, CA 94043

Salary : $185,000+ Dependent on Experience

Direct Hire

Job Responsibilities :

• Lead all Quality Assurance functions for both commercial and clinical products manufacturing and development
• 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

Qualifications and Experience :

Please submit an updated version of your resume for immediate and confidential consideration. Thank you!

Qualifications

Qualifications and Experience :

Please submit an updated version of your resume for immediate and confidential consideration. Thank you!

Additional Information

Please submit an updated version of your resume for immediate and confidential consideration. Thank you!

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