- Responsible for the development of systematic control and management processes for GxP documents throughout their lifecycle and for establishing procedures to ensure records (paper and electronic) are maintained in compliance with global regulatory and legal requirements, as well as site requirements and procedures.
- Responsible and accountable for the development, deployment and implementation of effective and efficient standards, procedures, and best practices for global and site documentation management and control including periodic review, change process, retention and archival.
- Maintains the global Quality Manual and global Quality Standards, and any associated global policies, reports, or documents.
- Assists in developing the overall global Quality Standards strategy and implementing the quality documentation hierarchy for global and site documentation, including development of process for gap assessments and implementation planning.
- Engages process owners and SMEs to ensure quality standards are appropriately defined, implemented, and/or updated to include current regulatory strategy and are contemporaneous with industry standards.
- Leads the development of reporting on quality standards implementation across all functions.
- Accountable for development and management of effective documentation system KPIs, metrics, management review, and proactive issue identification and resolution.
- Partners, educates, and collaborates with Documentation Control, QA, and SOP authors/owners in other functional areas for the development, deployment and maintenance of the document management program and records retention schedule.
- Business process owner for the electronic documentation management system. Partner with IT to implement, administer, maintain, and continuously improve the electronic documentation management system.
- Manages the document change request system at the global and regional level and provides guidance at the site level.
- Provides support during internal and external audits, including Regulatory Health Authority inspections.
- Ensures the documentation system is scalable and flexible to support initiatives and communicates effectively with all cross functional and regional stakeholders on matters related to the documentation system and e-DMS.
- Serves as subject matter expert for the regional change control system and associated requirements.
- Develops standards and guidelines for change control inputs and requirements needed to support change control requests.
- Oversees and administers the Change Control Board for regional/global Change Control requests and provides guidance at the site level.
- Leads the electronic change management governance process and serves as administrator to the e-system.
- Interfaces with IT as the Business Process Owner for the electronic change management system. Develops and prioritizes system enhancements and added functionality based on business need.
- As needed, works Quality Assurance and functional area representatives or responsible change owners to develop change management strategies.
- Develops and provide reports on change management process and progress for global dashboard.
- This role may have direct reports. The role also functions as an individual contributor role in a heavily matrixed environment.
- Incumbent will be expected to complete all assigned GxP and Compliance related training in accordance with assigned due dates.
- Phone conferences outside of normal working hours is required in order to interact with global counterparts.
- Travel is required at approximately 15%.
- BA/BS in the Life Sciences is required. MS degree in Life Sciences a plus.
- 7-10+ years experience in Document Management and Control and 3-5 years experience in Change Management in FDA-regulated, GxP-related Industry is required.
- Comprehensive knowledge of document control principles, data integrity principles, and good documentation practices a must.
- Demonstrated experience with implementation and management of electronic document management systems required.
- Working knowledge of electronic change management systems or e-QMS required.
- Experience with writing and approving Standard Operating Procedures and Quality Standards.
- Ability to drive Quality projects for continuous improvement.
- Thorough knowledge of ICH Guidelines and FDA cGMPs and Guidelines is required.
- Knowledge of European and Japanese Health Authority requirements is a plus.
- Ability to work independently with minimal supervision is required.
- Demonstrated ability to interact and communicate effectively with peers, senior management, regulatory officials, and auditors. Proven interpersonal skills with face to face and remote teams.
- Position will be filled at level commensurate with experience.
- Strong computer skills are required.
- Excellent oral, written, and verbal communication skills are required.
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