Director, Quality Assurance (QA)

Company: TargetCW
Location: Mountain View
Posted on: September 17, 2020

Job Description:

Full-time

Company Description 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 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:

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!

Qualifications 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!

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

Keywords: TargetCW, Mountain View , Director, Quality Assurance (QA), Other , Mountain View, California