We are seeking a dynamic and hands-on Senior Specialist to join our Quality team at our new Alameda cell therapy manufacturing facility. In this fast-paced, collaborative CDMO environment, you’ll be a key quality partner providing front-line support to both manufacturing and quality control (QC) teams. This role is ideal for an experienced quality professional with strong technical judgment, a continuous improvement mindset, and the confidence to engage with clients and cross-functional stakeholders.

QUALIFICATIONS

• Bachelor’s degree in a life sciences or related discipline required
• Minimum 5 years of experience in QA, QC, or Manufacturing within a GMP-regulated biopharma environment; prior experience supporting QC analytical testing or investigations is required
• Experience in cell and gene therapy, CDMOs, and/or startup biotech strongly preferred
• Solid understanding of FDA and EU GMPs, and experience supporting batch disposition activities
• Strong verbal and written communication skills, with the ability to interact confidently with internal teams and external clients
• Proficiency in MS Office; experience with electronic quality systems such as Veeva and LIMS is a plus
• Proven ability to work independently, prioritize effectively, and drive results in a fast-paced environment

• Provide QA oversight of both manufacturing and QC analytical operations, including review and approval of batch records, QC test records, and associated investigations
• Partner with QC and manufacturing teams to triage floor issues in real time, lead or support impact assessments, and ensure appropriate immediate actions are taken
• Serve as QA reviewer and approver for deviations, CAPAs, OOS investigations, and non-conformances, with a focus on root cause analysis and timely closure
• Act as the primary QA point of contact for weekly client interactions, addressing inquiries, supporting audit readiness, and presenting documentation related to batch disposition and investigations
• Represent QA on cross-functional and client-facing project teams, contributing quality expertise to process improvements, technical transfers, and operational readiness efforts
• Identify trends or recurring issues and contribute to quality system enhancements or procedural improvements
• Draft, review, and/or approve GMP documentation, including SOPs, protocols, reports, and logbooks
• Promote a culture of compliance, right-first-time execution, and continuous learning in alignment with cGMP expectations and internal policies