Senior Director, Quality Control

Company: Arsenal Biosciences
Location: Hayward
Posted on: March 22, 2025

Job Description:

WHO WE AREArsenal Biosciences Inc. is a clinical-stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We seek a talented and experienced Sr. Director, Quality Control to work ONSITE based in our HAYWARD office.ArsenalBio's mission and purpose are very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines to attack cancer's inherent multifaceted nature and overcome the challenges of addressing solid tumors with cell therapy.Driven by a collective of diverse experts across multi-scientific disciplines and clinical and manufacturing expertise, we are united in our purpose to develop the optimal medicines for improving patients' lives.This means you'll have the opportunity to work with the best talent in the field of cell therapy and be part of ONE TEAM, which advances therapies for patients who need it most.You will develop and provide vision for the advancement and management of the Quality Control function including strategy and compliance. The Sr. Director ensures the QC function evolves through phases of development, progressing the organization design, capabilities, and operations to support advancement to pivotal clinical trials and later commercial product phase. The Sr. Director is ultimately accountable to ensure the team is organized to ensure establishment of team priorities to meet overall project targets and timelines now and in the future.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.MINIMUM QUALIFICATIONS
• 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, and other Quality documents.
• Expert knowledge of phase appropriate cGxPs and experience leading Quality Control implementation and continuous improvement efforts.
• Experience with both US and ex-US compliance expectations related to QC.
• Direct experience with quality investigations, assessments, reviews and/or evaluations of Quality events (CAPAs, deviations, change control, Lab Investigation/ OOS, etc.).
• Team player with the ability to work in a collaborative, fast-paced team environment.
• Strong written and verbal communication skills and experience with working in cross-functional teams.
• Proven leadership skills and strategic problem-solving ability; ability to foresee issues and identify solutions with a flexible mindset.
• Excellent problem-solving skills and experience with root cause investigations and CAPA determination.
• Ability to lead successfully within extended project teams and handle multiple challenges under pressure.
• Excellent organizational skills: Proactive management of multiple tasks of varying complexity simultaneously.
• Ability to negotiate extremely critical matters with internal and external executive level management.
• Ability to influence policy making and strategy based on communication strategies and persuasion skills.
• Partners with the executive leadership team for the function to provide cohesive direction towards company goals.
• Recognized as an influential leader.
• Ability to lead business and technical briefings for senior and top management and for external representatives.PREFERRED QUALIFICATIONS
• Advanced degree in relevant scientific field or discipline.
• Experience working and influencing in a cross-industry setting.BENEFITS AND PAYArsenalBio has a generous and comprehensive benefits package that includes but is not limited to medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra "Arsenal Days of Rest" every quarter for employees to recharge.Our people-first culture cultivates a deep respect for humanity, not only in those we serve but also in one another. We take pride in being part of a company that values and celebrates diversity-in experiences, ideas, and interests. We are empowered in an environment that embraces unity and inclusivity, fostering a sense of belonging and mutual respect.We provide powerful tools to empower our employees to take charge of their career paths and reach their full potential. At ArsenalBio, we believe in investing in our employees' well-being-both professionally and personally-because our people are our most valuable asset. Our essential team members bring exceptional expertise in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software, and other fields to turn the possibilities of tomorrow into the realities of today.We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.We are an equal opportunity employer and deeply value diversity within our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability.The estimated base salary for the preferred primary location of the San Francisco Bay area ranges from $231,300-$283,300. Salary ranges for other locations may vary. Base pay offered may vary based on job-related knowledge, experience, education, and location. Beyond these considerations, we are committed to pay equity and consider the internal equity of our current employees when making any final offers.
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Keywords: Arsenal Biosciences, Hayward , Senior Director, Quality Control, Executive , Hayward, California