Manager, Quality Assurance Operations

• Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred)
• 7+ years of experience in Quality Assurance within GMP-regulated biopharmaceutical or cell/gene therapy manufacturing
• Strong experience supporting CMO oversight and external manufacturing environments

• Deep knowledge of: cGMP regulations (FDA, EMA, ICH guidelines), Deviation, CAPA, and investigation processes, Change Control systems and validation lifecycle
• Knowledge of lentiviral vector process preferred
• Knowledge of process validation preferred
• Strong understanding of cell/gene therapy manufacturing or biologics

• Demonstrated ability to lead cross-functional quality governance forums
• Strong risk-based decision-making and escalation capabilities
• Excellent communication, stakeholder management, and influential skills in internal and external settings
• Ability to operate effectively in a fast-paced, matrixed CMO environment
• High attention to detail with an inspection-ready mindset

• Proactive risk identification and escalation during manufacturing operations
• Timely closure and high-quality management of deviations and investigations
• Strong, compliant oversight of CMO operations and quality systems
• Effective cross-functional collaboration and governance leadership
• Continuous improvement of quality systems and performance metrics

The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting.

We may ultimately pay more or less than the posted range, and the range may be modified in the future.

This role is eligible for an annual bonus and long-term incentive.

Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.

Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.

All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.