Director, Quality Assurance (QA)

TargetCW Sandbox; Mountain View (CA); On-site; USD 166,500 - 203,500; Full time

Job summary

TargetCW Sandbox in Mountain View, CA is seeking a Director of Quality Assurance. The role involves leading all QA functions, ensuring compliance with regulatory requirements, and developing quality systems. Ideal candidates will have 10+ years of QA experience in the pharmaceutical industry and a BS in a related field. The position offers a competitive salary starting at $185,000, dependent on experience.

This is an excellent opportunity to work with a leading venture-backed pharmaceutical company focused on innovative treatments for central nervous system conditions.

Qualifications

• 10+ years Quality Assurance experience in the pharmaceutical and/or medical device industry.
• Experience in drug/device combination products is a plus.
• Comprehensive knowledge of cGMP regulations (US and EU) and Quality Systems.

Responsibilities

• Lead all Quality Assurance functions for commercial and clinical products.
• Develop, implement, and maintain quality systems to ensure compliance.
• Serve as primary interface with Regulatory Agency inspectors.

Skills

Quality Assurance experience

Leadership ability

Excellent communication skills

Knowledge of cGMP regulations

Problem-solving abilities

Education

BS in Life Sciences, Chemistry or related disciplines

Job 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

• 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