GMP Quality Systems Lead – Document Control

Lonza Group Ltd.; 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‑s­

Employee assistance programs

Paid time off (PTO)

Job summary

Lonza Group Ltd. in Pearland, TX is seeking a Quality Systems Supervisor – Document Control to oversee all document control operations and quality system documentation on-site.

You will supervise the Document Control team, serve as the primary contact for site QA Document Control, ensure GMP compliance, support audits, and manage the Electronic Document Management System (Documentum) configuration and user access.

Qualifications

• Experience in document control, quality systems, or GMP-regulated environment.
• GMP experience is required.
• Experience with document management systems (Documentum, Veeva or similar).
• Prior leadership or supervisory experience.

Responsibilities

• Supervise and oversee all document control program responsibilities including issuance of controlled documents, document change control processes, DMS workflows, and record archival.
• Serve as the primary point of contact for site QA Document Control and support cross-functional teams including research, quality, and process development.
• Act as system owner and administrator for the Electronic Document Management System (e.g., Documentum), including system configuration, user setup, and troubleshooting.
• Train employees on document management systems and departmental processes.
• Provide direct supervision of Document Control team members including coaching, performance management, career development, hiring, and onboarding.
• Assess resource needs and support staffing activities including hiring and contractor onboarding.
• Develop and implement process improvements and author/revise procedures as needed.
• Manage off-site record storage, including archival and retrieval through systems such as Iron Mountain.
• Ensure compliance with record retention schedules and document lifecycle requirements.
• Support internal and external audits and regulatory inspections.
• Develop and present metrics to leadership to monitor document control performance and drive continuous improvement.
• Perform QA review and approval of quality system records including change controls, deviations, CAPAs, investigations, and controlled documents.
• Perform other duties as assigned.

Skills

Leadership experience

Strong communication

Multi-tasking / prioritization

Cross-functional collaboration

Business software proficiency

GMP knowledge

Document control processes

Education

Bachelor's degree preferred

Tools

Documentum

Veeva

Job description

Lonza Group Ltd. in Pearland, TX is seeking a Quality Systems Supervisor – Document Control to oversee all document control operations and quality system documentation on-site.

You will supervise the Document Control team, serve as the primary contact for site QA Document Control, ensure GMP compliance, support audits, and manage the Electronic Document Management System (Documentum) configuration and user access.