Senior Director, Quality Control (25025-B-682-QC)

WHAT YOU’LL DO

• Develops and provides vision for the advancement and management of Quality Control strategy and compliance; ensure the QC function evolves with the appropriate clinical phase of development progressing the organization design and capabilities to support advancement to pivotal clinical trial and later commercial product phase and the team is organized to ensure establishment of team priorities to meet overall project targets and timelines.
• Establish and ensure execution of QC expansion strategy, including potential new laboratory facility design, and expansion of QC organization technical capabilities related to raw material testing, and QC microbiology.
• Responsible for authoring or approving QC relevant portions of regulatory submissions (IND/BLA).
• Work with senior management to integrate quality risk management concepts and philosophies into the Quality Control processes.  Support authoring of quality standards and standard operating procedures, as needed.
• Review documents for accuracy, completeness, and compliance. Identify and implement changes needed for existing QC documentation processes to support continuous improvement.
• Serve as a change agent, training colleagues and providing understanding of QC compliance expectations and training, ensuring compliance of these practices across QC and functions supporting QC.
• Develop the overall QC strategy and framework development for new and emerging initiatives, recommending operational plans and strategies that will directly impact the achievement of overall functional results and compliance status of ArsenalBio QC.
• Manage and mentor team members, ensuring appropriate employee development and organizational succession planning is in place for ongoing functional continuity.
• Establish processes for accurately tracking, reporting, and analyzing QC assay and standards performance.
• Lead high-performing teams focused on initiatives related to analytical knowledge and Quality Process / Quality Documentation improvements, including lab investigations, deviations, OOS, change control, and CAPA.
• Promote continuous improvement using Lean and Six Sigma principles.
• Perform internal/external Quality audits and technical visits as needed
• Serve as deputy to other Quality functional heads, Eg. Quality Systems and Compliance, QA Operations as needed.
• Lead cross-functional initiatives as needed.
• Position requires on-site presence across ArsenalBio sites in the California Bay-Area, and may require additional travel outside of the bay-area 10 – 15% of the time.

• Bachelor’s degree in relevant scientific field or discipline
• 15+ years progressive experience and strong background in Quality/Quality Control in the drug development industry with knowledge of cGMP/ICH/FDA/EMA expectations with at least 5+ years’ experience leading and developing teams in a QC function.
• Prior experience in Quality/Analytics for cell therapy products in late-stage clinical (pivotal trial) or commercial phase.
• Demonstrate a quality mindset and ability to influence across the organization
• Demonstrate analytical and critical thinking skills, and issue resolution skills
• Effective experience writing and reviewing SOPs, Policies,