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!
Similar Jobs
Biotech
Leads GMP quality assurance strategy and execution for clinical-stage oral recombinant vaccine programs. Oversees quality systems, audits, supplier qualification, batch record and laboratory data review, deviations, CAPAs, change controls, stability, product release, regulatory inspections, and inspection readiness. Partners with CMC, Quality Control, Regulatory, Clinical Supply, and external manufacturing and testing organizations to ensure compliance, product quality, data integrity, patient safety, and supply continuity.
Top Skills:
CgmpElectronic Quality Management SystemsEma RegulationsFda RegulationsGmpIch GuidelinesMastercontrolTrackwiseVeeva Qms
Biotech • Pharmaceutical
Leads global GCP quality assurance governance, compliance oversight, risk-based audits, inspection readiness, vendor oversight, CAPA management, and quality management system improvements across clinical programs. Provides expert guidance on global regulatory requirements, supports clinical and regulatory submissions, manages quality metrics and trends, and mentors QA staff, consultants, and auditors. Partners cross-functionally to protect patient safety, ensure data integrity, and drive continuous improvement.
Top Skills:
EdmsEmaEu Annex 11FdaFda 21 Cfr Part 11Ich GcpMhraNmpaPmda
Biotech • Pharmaceutical
Provides global GCP quality assurance oversight for clinical programs, vendors, audits, CAPAs, inspection readiness, and regulatory compliance. Leads study and vendor audits, evaluates risks, reviews clinical and regulatory documentation, supports QMS development, analyzes quality metrics, and drives continuous improvement. The role requires expertise in global GCP regulations, clinical trial quality systems, vendor oversight, regulatory inspections, data integrity, and patient safety.
Top Skills:
21 Cfr Part 11EdmsElectronic Data Management PlatformsElectronic Document Management SystemsEu Annex 11Ich Gcp
What you need to know about the San Francisco Tech Scene
San Francisco and the surrounding Bay Area attracts more startup funding than any other region in the world. Home to Stanford University and UC Berkeley, leading VC firms and several of the world’s most valuable companies, the Bay Area is the place to go for anyone looking to make it big in the tech industry. That said, San Francisco has a lot to offer beyond technology thanks to a thriving art and music scene, excellent food and a short drive to several of the country’s most beautiful recreational areas.
Key Facts About San Francisco Tech
- Number of Tech Workers: 365,500; 13.9% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Google, Apple, Salesforce, Meta
- Key Industries: Artificial intelligence, cloud computing, fintech, consumer technology, software
- Funding Landscape: $50.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Sequoia Capital, Andreessen Horowitz, Bessemer Venture Partners, Greylock Partners, Khosla Ventures, Kleiner Perkins
- Research Centers and Universities: Stanford University; University of California, Berkeley; University of San Francisco; Santa Clara University; Ames Research Center; Center for AI Safety; California Institute for Regenerative Medicine
