7 Jobs in Mountain View, CA
TargetCW Sandbox is Hiring a Director, Quality Assurance (QA) Near Mountain View, CA
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!
Job Summary
Full Time
$186k-229k (estimate)
03/14/2024
07/20/2024
The job skills required for Director, Quality Assurance (QA) include Leadership, Quality Assurance, Quality Management, Written Communication, ISO, etc. Having related job skills and expertise will give you an advantage when applying to be a Director, Quality Assurance (QA). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Director, Quality Assurance (QA). Select any job title you are interested in and start to search job requirements.
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