Manager, Document Control, Training

Role Overview

• Manage and oversee day-to-day operations and lead continuous improvement efforts in the Quality Management System (QMS), including Document Change Control, Document Control, and Training, to support GxP compliance across multiple areas.
• Responsible for supporting and overseeing Document Control activities for documents used in GxP operations (includes manufacturing, clinical, regulatory, and product quality related documents) and archiving activities.
• Facilitates and supports the creation, revision, and obsolescence of GxP controlled documents, to include reporting, periodic review, and trend analysis.
• ACE administration: management of the eDMS (document change requests, training) and records management.
• System administration activities such as creating, monitoring and maintaining Users, Groups and Roles, and Entities (e.g., workflows) within the ACE system.
• Record Archival in Ace: Ensuring GxP records are stored in the ACE system. Utilizing the appropriate ACE workflow to store documents.
• Support onboarding of new employees in Quality Management System.
• Update document control procedures to ensure compliance with GDP (Good Documentation Practices) and relevant GxP regulations and standards for document review, approval, release, retrieval, storage, and retention.
• Collaborates with multidisciplinary teams to assist standardize activities within and across quality systems by preparing SOPs and quality processes.
• Measure and analyze metrics on change requests and quality records.
• Provides input and assistance towards inspection readiness activities.
• Assist in investigating and completing actions related to the audit findings.
• Act as the subject matter expert for document change control system and training program for Secura Bio, Inc. and during internal and external audits.
• Broad understanding of the processes, procedures, and systems used to accomplish the team’s work and familiarity with the underlying concepts in other disciplines within the function.
• May assist in Vendor management activities and Quality Management Review (QMR)
• Other duties as assigned.

Requirements

• 8+ years of relevant and progressive experience with implementation and management of QA Quality Systems, QA Documentation processes and Good Documentation Practices in the drug, biopharmaceutical, or medical device fields.
• Knowledgeable in use of computers and applicable software (MS Windows, MS Office, PDF generation, electronic security implementation, and hosted server applications.
• Experience with electronic document control systems compliant to FDA 21 CFR Part 11
• Demonstrated knowledge of FDA regulations and ICH guidance for drugs, biologics and devices as well as international standards for devices.
• Knowledge of process design and implementation, change control, auditing, and document management systems.
• Demonstrated detail-oriented, strong organizational, management, and communication skills.
• Ability to multi-task and prioritize projects to achieve established goals and objectives.
• Ability to balance and prioritize multiple projects, duties, and assignments.
• Ability to adapt to a fast-paced, team-oriented work environment.
• Ability to promote cooperation and teamwork among team members.
• Ability to analyze, troubleshoot, and resolve problems/issues as they arise.