Head of Quality

About Multiply Labs

Multiply Labs is a cutting-edge startup based in San Francisco, California, supported by top-tier tech and life science investors such as Casdin Capital, Lux Capital, and Y Combinator. We are revolutionizing the manufacturing of cell therapies by developing advanced robotic systems designed to automate and scale the production of these life-saving treatments. Our robots empower biopharma companies to produce cell therapies at scale without significantly changing their existing processes, reducing regulatory barriers and risks. While traditional approaches are time-consuming and lead to extremely high costs for patients (typically $1M per patient), using robotics can make these transformative treatments more accessible and affordable to patients in need.

To learn more and to view a video of our robots in action, visit us at www.multiplylabs.com  and follow us on LinkedIn. You can also read our latest peer-reviewed study, which highlights the statistical equivalence between manual and automated cell expansion processes, at cytotherapy.org.

Position Overview:

As the Head of Quality, you will lead the development and implementation of a robust ISO 9001:20XX quality system to ensure compliance with industry standards in a cGMP-regulated pharmaceutical and biopharmaceutical environment. Reporting directly to the CEO, your primary focus will be aligning quality initiatives with customer and regulatory requirements.

As the Head of Quality, your role will include the following:

• Build and lead a quality team to develop and continuously improve the ISO-based quality system.
• Define and implement a comprehensive quality strategy in alignment with ISO 9001:20XX and regulatory standards.
• Provide strategic insight on evolving regulatory requirements in the biopharmaceutical industry.
• Oversee quality agreements, product release processes, and supplier qualification, including managing contract fabricators and key suppliers.

• Develop and maintain policies and procedures to support a robust quality system, including validation and compliance with 21 CFR Part 11.
• Oversee and automate the document control system, ensuring review and approval of all key documentation (policies, procedures, validation reports, etc.).
• Establish systems for tracking quality trends, audit findings, CAPA progress, and continuous improvement metrics.
• Manage change control systems, deviation systems, CAPA (Corrective and Preventive Actions), and continuous improvement programs.

• Oversee risk management processes, including compliance with GAMP 5 software lifecycle requirements and 21 CFR Part 11 for electronic data integrity.
• Lead internal and external audits to ensure regulatory compliance.
• Host customer audits and manage corrective actions.

• Train staff on quality system requirements, validation processes, and regulatory compliance standards.
• Define hardware and software validation requirements and ensure compliance with ISO and regulatory standards.
• Work with the engineering teams to establish product release procedures and achieve CE mark certification.
• Participate in problem investigations and cross-departmental initiatives to support continuous improvement.

• BS or MS in science or engineering
• A minimum of 7-10 years of increasing quality management experience in the bio/pharmaceutical or medical device industries.
• In-depth knowledge of quality management principles, cGMP’s, equipment and software validation practices with the ability and pragmatism to adapt requirements to a non-regulated equipment manufacturing environment.
• Strong organization and communication skills.
• Excellent interpersonal skills across functional groups and lines of authority.

• A diverse background in quality management (ASQ - Quality Engineer).
• Work experience in an ISO 9001 manufacturing environment.
• Experience in cell/gene therapy manufacturing (industry requirements, state-of-the-art quality and regulatory approaches).
• Experience in regulatory affairs (RA). For example, writing communication documents with the FDA and/or the EMA.

Benefits

Total compensation includes generous equity and benefits including:

●         Health Insurance

●         Dental Insurance

●         Vision Insurance

●         Health Savings Account

●         Daily catered lunch

●         Commuter Benefits

●         Flexible PTO

●         401K

Multiply Labs is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Salary : $150,000 - $190,000