The QS Document Control Manager will have the overall responsibility to implement and sustain the CBM document management system ensuring compliance with internal requirements and external GMP regulations. The ideal candidate will be responsible for a high level of understanding of the standards and principles of GMP document life cycle, control and data integrity. The QS Document Control Manager will partner with business functions to ensure the successful implementation of the document management program. This role will require the strategic capability in the form of implementation and ownership (including policies, procedures, leading governance, and quality performance monitoring efforts, etc.). In addition to serving as a subject matter expert in these areas, the role will be responsible for maintaining strong, collaborative partnerships with cross-functional and cross-site team members and to implement a successful program.
- Maintain a GMP-compliant document management system.
- Plan and execute multiple tasks to ensure controlled documents are managed per procedures and applicable regulations.
- Maintain controlled document files (hard copy and electronic).
- Issue controlled documents in accordance with applicable procedures.
- Manage the document management system (Veeva) according to procedure.
- Act as Subject Matter Expert (SME) for document control and data integrity principles.
- Proven manager, mentor, and team developer, with the ability and desire to grow an organization, and facilitate the dynamics of growth and achieving goals.
- Create and provide training to personnel on the document management system.
- Represent document control at internal meetings and during site audits.
- Act as Business Owner for electronic systems used for document management.
- Develop and track Key Performance Indicators/Metrics and facilitates continuous improvements of CBM’s document life cycle and control
- Provide support on various other projects as necessary, ensuring appropriate document control is maintained.
- Other duties as required and necessary to ensure the success of the organization.
- Bachelor’s Degree in a scientific or business field of study
- 10+ years’ experience in the Pharmaceutical industry supporting GMPs or equivalent industry; 3+ years of experience in a document control position, preferred.
- Strong technical knowledge, skills and experience in project and documentation management.
- Direct experience with the use of Veeva Vault documentation system.
- Experience in Microsoft tools such as Outlook, Word, Excel, PowerPoint, SharePoint, Teams and Project is strongly preferred.
- Experience with document editing in MS word (e.g. formatting, forms, styles, templates, etc.).
- Experience directly related to the development of Quality Standards and core requirements for Market Supply and / or Clinical Supply.
- Experience directly related to Quality Assurance, Quality Control, GMP regulations or pharmaceutical regulations.
- Knowledge of processing mapping and optimization.
- Working knowledge and understanding of GMPs for pharmaceuticals.
- Skilled in multitasking while maintaining attention to detail.
- Excellent organizational and time management skills.
- Skilled in effective communication, written and verbal.
- Demonstrated ability to work effectively with colleagues having a broad range of responsibilities, functional and cultural.
- Strong problem solving and customer service skills.
- Ability to use individual discretion in completing work assignments, establishing priorities, and working collectively to accomplish deadlines and objectives.
- Ability to change direction and respond to new situations which require immediate attention.