Director, Quality Control

About the role

This role provides Quality leadership during a pivotal period of organizational growth, balancing hands-on GMP execution with strategic Quality oversight. The Director, Quality Control oversees GMP manufacturing quality activities, drives phase-appropriate Quality governance, and ensures robust oversight of batch records, change controls, deviations, and clinical release decisions. This temporary bridge leadership position offers the opportunity to shape future Quality strategy, support progression toward late-stage development and BLA readiness, and potentially transition into a permanent role if mutually desired. This is a Contract position based out of Redwood City, CA. The position is hybrid.

Responsibilities

• Provide executive-level Quality leadership for GMP manufacturing operations, ensuring strong oversight of Quality systems and processes.
• Review and approve batch records to ensure compliance with GMP standards, data integrity expectations, and phase-appropriate requirements.
• Lead and oversee change control review and management, ensuring changes are adequately assessed, justified, documented, and implemented in a controlled manner.
• Direct deviation review and management, including investigation oversight, root cause analysis, corrective and preventive actions, and timely closure.
• Make sound, risk-based Quality decisions that support clinical supply, patient safety, and regulatory expectations while enabling operational efficiency.
• Provide independent Quality oversight of GMP manufacturing activities while partnering closely and constructively with Technical Operations.
• Support GMP Manufacturing Quality activities, including Materials Review Board decisions and clinical release support for investigational products.
• Lead, mentor, and develop a smaller QA team, fostering a culture of accountability, operational ownership, and continuous improvement.
• Assess and manage Quality risk across ongoing manufacturing activities, applying a phase-appropriate Quality mindset aligned with clinical development stage.
• Collaborate cross-functionally with Technical Operations and other functions to ensure alignment between Quality governance and operational execution.
• Support the design, implementation, and oversight of Quality systems and validation activities appropriate for cell therapy, gene therapy, and other biologics modalities.
• Influence and contribute to Quality strategy and readiness for late-stage development and potential BLA submissions.
• Demonstrate hands-on leadership in a lean biotechnology environment, actively engaging in daily operations and decision-making.
• Communicate effectively with technical leaders, including executive stakeholders, to ensure Quality perspectives are integrated into strategic and operational plans.

Skills

• Strong GMP Manufacturing Quality experience with a focus on biologics and complex modalities.
• Demonstrated expertise in batch record review for GMP manufacturing operations.
• Proven experience in change control review and management within a regulated environment.
• Extensive experience in deviation review and management, including investigations and CAPA oversight.
• Strong Quality decision-making skills grounded in risk management and regulatory expectations.
• Experience providing manufacturing quality oversight in clinical and early-stage environments.
• Quality assurance management experience with the ability to lead and mentor smaller QA teams.
• Ability to provide independent Quality oversight while effectively partnering with Technical Operations.
• Phase-appropriate Quality mindset, with clear understanding of how expectations differ between early-stage clinical and commercial organizations.
• Experience with Quality systems and validation activities in GMP settings.
• Experience in biological sciences or related field, with familiarity in cell therapy, gene therapy, and biologics manufacturing.
• Strong communication skills and the ability to influence cross-functional teams and stakeholders.
• Ability to balance operational execution needs with robust Quality governance in a fast-paced environment.
• Capability to transition into permanent employment if mutually agreed.
• Preference for experience in cell therapy manufacturing environments.
• Preference for experience in vector production and gene therapy operations