Quality Systems Supervisor - Document Control

Lonza • Houston, TX

6d • Onsite

About The Position

The Quality Systems Supervisor – Document Control will oversee all document control operations and quality system documentation activities at the site. This role acts as the primary liaison for document management processes, ensures compliance with GMP requirements, and provides leadership and direction to the Document Control team. The position is responsible for maintaining document management systems, driving process improvements, and supporting audits and inspections while ensuring efficient and compliant handling of quality records.

Requirements

• Experience from 3 to 5 years in document control, quality systems, or a related GMP-regulated environment.
• GMP experience is required.
• Strong understanding of document control processes and quality systems.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong communication skills and ability to collaborate across departments.
• Demonstrated ability to lead teams, resolve issues, and drive process improvements.
• Proficiency in standard business software including spreadsheets, databases, and document systems.

Nice To Haves

• Bachelor’s degree preferred but not required.
• Experience with document management systems (e.g., Documentum, Veeva, or similar platforms) preferred.
• Prior leadership experience (lead role or supervisory experience) preferred.

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.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree