Associate Director, Quality Assurance - Cell & Gene Therapy
Houston, TX - 100% Onsite
Why You'll Love This Opportunity
We're building more than just groundbreaking therapies-we're building a career destination. As a full-time, onsite member of this mission-driven biotech team, you'll work at the leading edge of innovation while enjoying best-in-class benefits that prioritize your health, growth, and work-life balance:
- Full individual medical, dental & vision insurance - effective the 1st of the month after your start date
- $500 annual company-funded FSA card to use toward medical expenses (no employee contribution required)
- Paid short-term & long-term disability + group life insurance (1x annual salary)
- Voluntary add-on benefits: spouse/child/family life, critical illness, accident, dependent care FSA, and pet insurance
- Tuition reimbursement to fuel your professional development
- Paid parental leave for both birthing and non-birthing parents
- 401(k) with 100% company match up to 6% of your salary
- Annual target bonus + profit-sharing bonus based on role and performance
- 20 PTO days in your first year + company holidays
Note: This role requires 100% onsite presence at our state-of-the-art facility in Houston, TX. Remote or hybrid work is not available for this position.
About the Role
We're seeking a Associate Director, Quality Assurance to play a key role in the oversight and advancement of QA systems for next-generation cell and gene therapies. As a senior member of our team, you'll ensure product quality, regulatory compliance, and inspection readiness across all stages of development and manufacturing. You'll be embedded in a collaborative, high-impact environment where your work directly contributes to getting life-saving therapies to patients.
What You'll Do
- Oversee line-clearance and change-over processes to ensure compliant manufacturing readiness
- Manage product disposition activities for raw materials through drug product
- Supervise the generation and reconciliation of product labels
- Review and approve documentation from manufacturing, QC, and support functions
- Lead investigations, deviations, CAPAs, and change controls within the QA function
- Partner cross-functionally to develop and optimize SOPs, batch records, and quality workflows
- Ensure robust quality systems by conducting audits, hazard analyses, and data-driven improvements
- Train and coach employees on quality procedures, regulatory expectations, and continuous improvement
- Lead and develop a team of QA professionals to meet performance and compliance goals
- Support hiring, onboarding, and team engagement within the QA organization
- Participate in cleanroom activities and raw material inspections when required
What You Bring
- Bachelor's degree in a scientific field (advanced degree a plus)
- 12+ years of progressive QA experience in FDA-regulated industries
- 6+ years in QA leadership or management roles
- Strong working knowledge of cell and gene therapy processes
- In-depth experience with cGMPs, GLPs, and other regulatory standards (FDA, EMA, etc.)
- Skilled in managing CAPAs, deviations, batch record reviews, and quality investigations
- Excellent communication, organizational, and leadership skills
- Proficient with Microsoft Office and quality systems (e.g., LIMS, QMS, SAP)