Quality Director

About Us:

Culture’s mission is to make bioprocess development and scale-up as fast and easy as scaling software. Towards this aim, Culture’s first offering enables biopharma, biotechnology, and synthetic biology companies to run their bioprocessing R&D in the cloud. Clients design, manage, and analyze bioprocess experiments in Culture’s Console web application. Culture’s offering enables customers to focus on designing and improving their process versus spending time and effort building out their own high-throughput process development laboratory. While customers remotely observe the process and analyze data, the experiments are executed in Culture’s cloud bioreactor facility in South San Francisco. The facility is enabled by Culture’s proprietary 250mL and 5L single-use bioreactor technology and software systems.

At Culture, we combine our passions for biomanufacturing, engineering, and operations to build new solutions that make bioprocess development and scale-up faster. We value curiosity, communication, collaboration, customer focus and a drive for results.

The Opportunity: 

Culture Biosciences is looking for a Quality Director. The Quality Director is responsible for overseeing the overall Quality function, with a particular emphasis on providing strategic and tactical leadership to support the Culture’s Quality Management System, ensuring quality oversight and compliance in all GxP related efforts across its manufacturing, services and new product development activities. This person will actively support and execute on Culture’s commitment to Quality and all quality objectives, with an emphasis on continual improvement.

What you'll do:

• Establish and maintain the Culture Biosciences’ Quality vision, mission, and strategy.
• Manage and provide leadership to Quality team members including on Quality Assurance, Quality Systems, and Quality Control.
• Assure quality products and processes by establishing and maintaining quality standards within the Quality Management System. Review and update the QMS: scope, policy, manual and procedures to assure compliance with regulatory requirements.
• Support daily operations of internal quality systems including the full document lifecycle for Nonconformity Reports (NCRs), Corrective Actions/Preventive Actions (CAPA), version controls/release of updated component and device drawings, and Bill of Materials (BOMs).
• Monitor and report on relevant KPIs and metrics to assess the effectiveness of the QMS.
• Actively participate in new product development cycles to ensure customer and defined requirements are achieved and appropriate regulatory matters are considered. Implement new product release controls for critical quality issues.
• Act as the liaison to external bodies/agencies for the purposes of achieving and maintaining certifications, as well as planning, scheduling, and carrying out both external and internal GxP audits and inspections and their follow ups.
• Assist with training on GxP and other quality-related topics.
• Perform special projects and additional duties as required.

About you:

• Bachelor's degree in relevant scientific field required, Master's degree preferred
• Minimum of 10 years experience with Quality Systems, QA, and QC within the life bioprocessing, biotechnology, or life sciences sector with at least 5 years managing a team or function
• Deep knowledge and understanding of GxP and regulatory requirements
• Experience with operational process improvement initiatives 
• Excellent foundational skills including strong analytical, written and verbal communication skills, compelling facilitation and presentation skills.

In return, we offer a supportive environment. We value:

• Lifting each other up and enabling others to be their best
• Commitment to reliability
• Empowering ownership to drive progress
• Trying new things; big innovations start with small ideas and actions

Location & Schedule: 

• This is a remote-flexible position. We’re looking for someone based in the San Francisco Bay Area who is able to work in person at our office in South San Francisco at least 3 days per week. 

Base Salary Range:

Culture Biosciences's compensation package includes market competitive salary, equity for all full time roles, and great benefits. Our expected salary range for this role is $175,000 - $215,000. We are hiring for multiple levels and backgrounds so final offers may vary within the range provided based on experience, expertise, and other factors.

Benefits:

• Competitive salary and equity compensation
• Medical, Dental, Vis