Deviations and Batch Records Manager

Lonza•Houston, TX

3d•Onsite

About The Position

As a Deviations & Batch Records Manager, you will lead a team responsible for deviation investigations and GMP quality record management in a fast-paced cell therapy and viral vector manufacturing environment. This role serves as a strategic quality leader and business partner to Manufacturing, Quality Assurance, Engineering, Supply Chain, and Program Management teams, ensuring investigations and quality records are completed accurately, compliantly, and on time to support product release, regulatory compliance, and operational excellence. You will play a critical role in driving continuous improvement initiatives, developing high-performing employees, and strengthening the site's quality culture while supporting life-changing therapies for patients.

Requirements

Bachelor’s degree in Biochemistry, Biology, Chemical Engineering, or another relevant scientific discipline required.
5+ years of experience in a cGMP-regulated pharmaceutical, biotechnology, cell therapy, gene therapy, biologics, or advanced therapies manufacturing environment.
Demonstrated leadership experience managing or leading deviation investigation, quality systems, or quality records teams.
Strong expertise in deviation investigations, root cause analysis, technical writing, and quality record management.
Experience independently managing complex investigations and supporting product release activities in a manufacturing environment.
Knowledge of cGMP regulations, data integrity requirements, CAPAs, quality systems, and regulatory inspection readiness expectations.
Excellent communication, conflict resolution, project management, and cross-functional collaboration skills.
Ability to influence stakeholders, drive organizational improvements, and build high-performing teams in a dynamic GMP environment.

Nice To Haves

Advanced degree preferred but not required.
Experience supporting cell therapy, viral vector, biologics, or other advanced therapy manufacturing operations preferred.

Responsibilities

Lead and oversee a team of deviation investigators and quality records professionals, ensuring accurate, compliant, and timely completion of investigations and GMP quality records.
Provide leadership, mentoring, coaching, and technical guidance to team members while supporting employee development, performance management, and succession planning.
Review and approve complex deviation investigations, root cause analyses, corrective and preventive actions (CAPAs), and quality records to support product disposition and regulatory compliance.
Partner closely with Manufacturing, Quality Assurance, Engineering, Validation, Supply Chain, and Program Management teams to facilitate timely resolution of quality events and support manufacturing operations.
Monitor departmental performance metrics, prioritize workloads based on business needs, and drive reduction of overdue investigations and quality records.
Serve as a strategic quality partner by identifying compliance risks, escalating critical quality issues, and ensuring appropriate mitigation activities are implemented.
Lead continuous improvement initiatives focused on investigation effectiveness, record closure cycle times, right-first-time performance, and inspection readiness.
Support internal audits, customer audits, and regulatory inspections through preparation of quality records, metrics, and subject matter expertise.
Develop and maintain procedures, work instructions, training materials, and governance practices related to deviation investigations and batch record management.
Lead departmental meetings, cross-functional forums, and quality governance reviews while fostering a culture of accountability, compliance, and operational excellence.