Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Position Summary
The Document Control Supervisor is responsible for overseeing the daily operations of the Document Control department to ensure the accuracy, integrity, and compliance of controlled documentation within the organization's Quality Management System (QMS). This position supervises document control personnel, manages document lifecycle activities, and ensures compliance with company policies and applicable regulatory requirements. The Document Control Supervisor partners with cross-functional teams to support quality initiatives, regulatory inspections, and continuous process improvement while fostering a culture of compliance and operational excellence.
Essential Responsibilities
- Supervise the daily activities of the Document Control team, ensuring work is completed accurately and within established timelines.
- Assign, prioritize, and monitor workloads to meet departmental and business objectives.
- Manage the document lifecycle, including document creation, review, approval, revision, distribution, archival, and retirement.
- Ensure all controlled documents are maintained in accordance with company procedures and regulatory requirements.
- Administer and maintain the Electronic Document Management System (EDMS), ensuring document integrity, version control, and audit trail accuracy.
- Review documentation for completeness, formatting, and compliance with document control standards.
- Develop, implement, and maintain document control procedures, work instructions, and related quality system documentation.
- Monitor document control metrics and identify opportunities to improve efficiency, compliance, and customer service.
- Support internal, customer, and regulatory audits.
- Collaborate with cross-functional teams to support document management activities.
- Ensure compliance with GDP, GMP, FDA regulations, ISO standards, and company policies.
- Lead document control investigations, Change Controls, CAPAs, and continuous improvement initiatives.
- Train, mentor, and develop Document Control staff.
- Support EDMS implementations, upgrades, validation, testing, and user training.
- Prepare reports and present document control metrics to management.
Minimum Qualifications
- Bachelor's degree in Business Administration, Life Sciences, Engineering, Quality, or related field.
- Five or more years of experience in document control, quality systems, records management, or a regulated industry.
- Two or more years of supervisory or team leadership experience.
- Experience in pharmaceutical, biotechnology, medical device, diagnostics, or manufacturing environments preferred.
Preferred Qualifications
- Experience with MasterControl, Veeva, TrackWise Digital, OpenText, SharePoint, or similar EDMS.
- Experience supporting FDA, ISO, customer, or regulatory inspections.
- Project management or continuous improvement experience.
Preferred Skills
- Knowledge of document lifecycle management and Quality Management Systems (QMS).
- Understanding of FDA 21 CFR Part 11, 820, GMP, GDP, and ISO standards.
- Strong leadership, coaching, organizational, analytical, and communication skills.
- Ability to manage multiple priorities while maintaining data integrity.
- Proficiency with Microsoft Office applications.
Core Competencies
- Leadership
- Quality Focus
- Customer Focus
- Collaboration
- Accountability
- Communication
- Problem Solving
- Decision Making
- Continuous Improvement
- Adaptability
- Organizational Excellence
Key Performance Indicators
- Timeliness and accuracy of document processing.
- Compliance with document control procedures and regulations.
- Audit readiness and inspection success.
- On-time document review and approval.
- Team productivity and customer satisfaction.
- Reduction in document errors and cycle times.
- Successful implementation of process improvements.