Lead and own all Quality Assurance functions for clinical and commercial product development and manufacturing. Develop, implement and maintain phase-appropriate quality systems (deviations/CAPA, change control, document management, validation, complaints, supplier oversight). Manage lot release, audits, CCB/MRB, regulatory inspections, quality reviews, departmental budget, and mentor QA staff while interfacing with corporate and regulatory partners.
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.
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!
QualificationsQualifications 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 InformationPlease submit an updated version of your resume for immediate and confidential consideration. Thank you!
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