Janssen Pharmaceutical Companies of Johnson & Johnson is currently recruiting for a Manager, Quality and Document Control to be based at a Janssen facility in one of the following locations: NJ, PA, UK, or Belgium.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Manager, Quality and Document Control will:
- Handled administration and lifecycle management of procedural documents supporting business partner in the electronic document management system (EDMS, i.e., truVAULT or equivalent).
- Oversee the day-to-day operations of the Quality and Document Control group, ensuring the highest quality and compliance of all document management deliverables.
- Collaborate with other members of the Quality Management group, in support of the development and revision of procedural documents.
- Oversee the quality review and consistency checks applied across the department, ensuring accuracy and clarity of content within and across documents. Strives for consistency across the department.
- Ensure the consistent use of the EDMS across the department. Identifies unused functionality that may further improve document management practices. Proposes enhancement requests and new, innovative approaches, in order to maximize the system’s benefits, streamline document processing and/or improve the customer experience.
- Handle resource planning across the procedural documents team and assignment of work to ensure documents are processed in a timely manner.
- Oversee all requests for procedural documents related to health authority inspections and internal audits.
- Ensure global coverage for responding to urgent requests in a timely manner.
- Provide support to the Janssen Pharmaceuticals Documentation Council for the administration and lifecycle management of cross-pharma procedural documents.
- Collaborate with the relevant stakeholders to ensure generation, QC and approval of monthly procedural document data in support of the Pharmacovigilance System Master File (PSMF).
- Oversee generation of routine reports.
- Maintain critical departmental tools, including the online request management tool, E2E Ownership Matrix, procedural documents tracker, deviations tracker, TOC, etc. Develops metrics and reports in support of organizational and customer needs.
- Resolve issues related to the EDMS, specific documents and document management practices in general.
- Collaborate with the Quality Analytics team to ensure seamless and efficient handover and user-friendly templates that align with the EDMS requirements.
- Build personal network with other document management groups within Janssen R&D to share and leverage best practices and optimal use of the EDMS.
- Foster strong working relationship across functions.
- Keep abreast of latest developments in Procedural Document management.
- A minimum of a Bachelor of Science (BSc) or Arts (BA) degree or equivalent degree is required
- A minimum of 8 years’ relevant experience in a medium to large scale matrix organization which includes applicable compliance related field and/or equivalent time and experience in a related R&D area is required.
- A minimum of 2 years’ experience in the field of document management, process design and/or training design is required
- Involvement with and/or experience leading Process Improvement projects is preferred
- Familiarity with Document Management Systems and Learning Management System functionalities is required. Knowledge of Business Process Management (BPM) tools and awareness of ongoing industry level Business Process Management Techniques is preferred.
- A track record in operational deliverables, thorough project planning and managing supportive capabilities is required
- Strong knowledge of sound research and development practices, scientific and quality terminology, industry quality assurance and management procedures and policies, and quality evaluation techniques is required
- A thorough knowledge of the drug development process and good knowledge of worldwide GxP compliance regulations is preferred
- Excellent organizational, analytical, strategic, interpersonal, written and oral skills required.
- Self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment is required
- Demonstrated strength in influencing and negotiation skills and ability to communicate effectively at all levels of the organization is required
- Ability to perform in a team and matrix organization, as well as adapt to a dynamic environment is required
- Strong personal leadership with demonstrated competency interfacing with senior leaders, strong networking and relationship building skills required
- Fluency (both written and oral) in English is required. Fluent means that you are completely comfortable communicating on a detailed, professional level
- This position may require up to 10% travel
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
United States-New Jersey-TitusvilleOther Locations
North America-United States-New Jersey, North America-United States-Pennsylvania, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-United KingdomOrganization
Janssen Research & Development, LLC. (6084)Job Function