Manager, Document Controls-00000SZE
Description
Janssen Supply Group, LLC is recruiting for a Manager, Document Controls. Any J&J based EMEA or US location will be considered for this role.
Janssen Pharmaceuticals Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. Janssen Supply Group, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
The Document Controls Manager will lead a team of SMEs to facilitate, design and execute Document Controls at JSC in support of Combination Products. The role will manage the implementation of the Document Controls processes and procedures as well as training and metrics reporting and create new quality frameworks for emerging platforms and technologies for Combination Products within JSC. The individual will lead a team to oversee the operations of the documentation systems in support of the QMS (Quality Management System) for Combination Products. This includes creation, review, revision, approval, and maintenance of combination product related documents required for regulatory compliance. He/she will drive alignment between local and global processes and ensure cost effective aligned and harmonized documentation management within Janssen Supply Chain. The Document Controls Manager will oversee the creation, review, revision, approval, and maintenance of all documents to ensure compliance with regulatory and J&J requirements. In addition the Document Controls Manager will manage the linkage and referencing of all applicable document packages. The individual will manage and/or lead audits to assess baseline compliance of Document Controls to JSC to the requirements of 21 CFR Parts 3, 4, 11, 210, 211 and 820 and Johnson & Johnson Policy Standards related to cGMP (Good Manufacturing Practice) for Combination Products, Pharmaceuticals, and Medical Devices. He/she will work with the Site Document Controls Product/Process Owners and the Quality organization to develop and implement a sustainable framework of Document Controls processes, procedures, tools, training and metrics to monitor the QMS.
The Manager, Document Controls is also responsible for: Recommending, initializing and/or sponsoring corrective and preventive actions and continuous improvement. Reporting the status of JSC Combination Product related documents within Document Controls Management System and providing periodic data and metrics for review. Ensuring that all documents required for regulatory compliance are reviewed for adequacy and approved prior to release. Ensuring that all documents required for regulatory compliance are available at all locations for which they are designated, used or otherwise necessary and that all obsolete documents are promptly removed from all points of use or otherwise prevented from unintended use. Ensuring change records are maintained for all documents required for regulatory compliance. Managing and ensuring the proper review of: Master Production and Control Records, Batch Production and control Records, Design History Files, Device Master Records, Device History Records. Managing the department QSR & cGMP document library. Providing support as needed during regulatory and partner inspections, including determining and maintaining cross functional staffing and other support resources. Counseling direct reports about work performance and development planning. Developing and delivering performance reviews. Continuously monitoring best Document Control practices to ensure JSC has adequate core knowledge, capability and resource bandwidth. Collaborating with all stakeholders and business partners to meet goals and objectives, identifying in J&J and Pharmaceutical sector initiatives related to device, combination product and emerging technologies product development and Quality Systems. Other related duties as assigned Acting as the SME for Document Controls for JSC Combination Products.
Qualifications
A Bachelor’s Degree in Chemistry, Biology, Engineering or other scientific discipline with a minimum of 6 years’ experience in medical device, pharmaceutical or biopharmaceutical industry OR an advanced degree with 2 years’ experience in the same industry. A minimum of 5 years’ experience with FDA CFR part 3, 4, 210, 211, 820 and/or ICH, ISO 13485, and industry technical standards relative to Combination Product development is required. Extensive experience with any of the following is required; ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purpose, European Medical Device Directive, and EN 62366 Human Factors. Extensive experience with automated Document Control Management Systems is required. Experience with DocSpace is preferred. Experience with FDA regulated CAPA is preferred. Knowledge & expertise in applying Combination Products cGMP regulations is preferred. Experience working in FDA regulated Quality Management Systems is required. Excellent technical writing skills; experienced in SOPs, protocols, reports is required. Demonstrated people leadership and management skills is required.
Qualified candidates must be experienced in MS Office. Excellent organizational skills, along with strong interpersonal, verbal, and written communications skills are required. Must be able to work effectively in team situations as well as independently. Must have the ability to multi-task, work with minimal supervision, and demonstrate resiliency and high productivity in a fast-paced environment is required, operating with a high sense of urgency while maintaining a high degree of professionalism. Experience supporting and working in a matrix organization is preferred. Must have the ability to communicate across all levels of the organization. Strong organizational, conflict management and decision-making skills are required. Must be able to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile, and rapidly changing environment.
The position may require up to 25% travel, domestic and international.
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Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:Europe/Middle East/Africa, North America-United States-Pennsylvania-Malvern, North America-United States-New Jersey-Raritan, North America-United States, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, North America-United States-Pennsylvania-Spring House, North America-United States-Puerto Rico-Gurabo, Europe/Middle East/Africa-Ireland-Cork-Cork, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Travel:Yes, 25 % of the Time
Job Function: Quality Systems
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