Deviations and Batch Records Manager

Lonza; Houston (TX); On-site; Confidential; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Short-term and long-term disability

Employee assistance programs

Paid time off

Job summary

Lonza is seeking a Deviations & Batch Records Manager to lead a dedicated team responsible for deviation investigations and GMP quality record management in a fast-paced cell therapy and viral vector manufacturing environment.

You will partner with Manufacturing, QA, Engineering, and Supply Chain to ensure timely, compliant investigations and records, driving continuous improvement and strong quality culture across the site.

Qualifications

• Leadership experience overseeing deviation investigations or quality records teams.
• Strong knowledge of cGMP regulations and data integrity.
• Experience with root cause analyses and CAPAs is preferred.

Responsibilities

• Lead and oversee a team of deviation investigators and quality records professionals.
• Mentor and coach team members; manage performance and succession planning.
• Review and approve complex deviation investigations and CAPAs; support product disposition.
• Collaborate with Manufacturing, QA, Engineering, Validation, Supply Chain, and Program Management.
• Monitor metrics; drive timely investigations and records closure; reduce overdue items.
• Identify compliance risks and implement mitigation activities; support audits and inspections.

Skills

Leadership

Deviation Investigations

Quality Records

cGMP Knowledge

Education

Bachelor’s degree in Biochemistry, Biology, Chemical Engineering, or related scientific discipline

Job description

Shift: Monday through Friday, 8:00 AM – 5:00 PM

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.

What you will get:

A competitive compensation package. In addition, below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus
• Medical, dental and vision insurance
• 401(k) matching plan
• Life insurance, as well as short-term and long-term disability insurance
• Employee assistance programs
• Paid time off (PTO)

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do:

• 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.

What we are looking for:

• Bachelor’s degree in Biochemistry, Biology, Chemical Engineering, or another relevant scientific discipline required.
• Advanced degree preferred but not 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.
• Experience supporting cell therapy, viral vector, biologics, or other advanced therapy manufacturing operations preferred.
• Ability to influence stakeholders, drive organizational improvements, and build high-performing teams in a dynamic GMP environment.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.

If you're ready to lead quality investigations, support cutting-edge cell therapy operations, and help drive compliance excellence across one of the world's largest advanced therapy manufacturing sites, we look forward to welcoming you on board.