Director, Quality Assurance (QA)

TargetCW • Mountain View, CA, United States • $200k - $250k / year • 2w ago

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. Their products 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 with 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:

BS in Life Sciences, Chemistry or related science disciplines
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
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 execute as well as lead
Ability to exercise judgment within broadly defined practices and policies to evaluate and solve problems
Solid understanding of pharmaceutical and medical device development

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

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