Manager, Document Control and Training
About the Role
The Manager of Document Control and Training is responsible for overseeing the document control and training processes and ensuring strict adherence to corporate policies, procedures, and applicable standards and regulations across reputed company company quality systems. This position will support reputed company. Global Quality, Regulatory Affairs, and Clinical Compliance. Employment Type Full-time Reports To Senior Director, Quality Assurance
Key Responsibilities
Manage and reputed company day-to-day operations and reputed company reputed company 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 reputed company 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) reputed company 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 reputed company 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 reputed company 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 reputed company to the audit findings. Act as the subject matter expert for document change control system and training program for reputed company. and during reputed company 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 reputed company the function. May assist in Vendor management activities and Quality Management Review (QMR) Other duties as assigned. Required Qualifications 8+ years of relevant and reputed company experience with implementation and management of QA Quality Systems, QA Documentation processes and Good Documentation Practices in the drug, biopharmaceutical, or medical device fields. This role will also be responsible for development and on-going maintenance of training and training curricula in the ACE training module. Knowledgeable in use of computers and applicable software (MS reputed company, MS Office, PDF reputed company, electronic reputed company 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 reputed company 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. Salary $121,000 to $142,000 Apply To This Job