Senior Manager, Quality Engineering & Validation (QA for QC)

Company: Arsenal Biosciences
Location: Hayward
Posted on: March 3, 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. Manager, Quality Engineering & Validation (QA for QC) 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.We are seeking a talented and motivated Senior Manager to join the ArsenalBio Technical Operations team. The individual will support ongoing Quality Engineering initiatives and provide technical expertise to other Technical Operations teams. The primary responsibilities will be to provide support to Quality Control as QA for QC. These activities include reviewing and approving QC Quality records (Change Control, Deviation, CAPA, and Lab Investigations), procedures/test methods, method qualifications/validations, equipment qualifications, and comparability protocols and reports. Additional activities that may be within scope of this role, as needed, are Commissioning and Qualification of equipment / utilities / facility, Computerized System Validation, and Risk Management. This position will report to Head of Quality Engineering & Validation.WHAT YOU'LL DO

• Partner with Quality Control group to determine phase appropriate commissioning, qualification, and validation strategies
• Review and approve C&Q documentation for technical soundness and compliance
• Provide oversight for C&Q related activities
• Review and approve QC Quality records, procedures, protocols, and reports as Quality Assurance.
• Provide support for deviations, change control, investigations, and CAPA, as needed
• Author, review, and/or approve process validation lifecycle documents, as needed
• Participate in Risk Assessments and facilitate as needed
• Promote a Quality mindset and continuous improvement
• Provide support with regulatory submissions (IND/BLA), as needed
• Provide support during internal and external inspections / audits, as needed
• Provide additional support to other functions, as requested by management, to support project milestones
• This position may require some travel, as neededWHO YOU ARE
• Bachelors or Masters in relevant scientific field or discipline
• 8+ years of experience in biotechnology/pharmaceutical industry
• In depth knowledge of analytical methods used in QC
• Prior experience in Quality for cell therapy products
• Strong knowledge of cGMP/ICH/FDA/EMA regulations
• In depth knowledge of QE principles, concepts, industry practices, and standards
• Strong technical writing and verbal communication skills
• Strong critical thinking and problem-solving skills
• Self-motivated, technically driven, and willing to take on duties outside of general responsibilities
• Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneouslyPreferred Qualifications:
• Ability to work in cleanroom environments
• Prior experience working in ASAT (Analytical Sciences & Technology)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 $162,000-$199,300. 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 Manager, Quality Engineering & Validation (QA for QC), Executive , Hayward, California