Provide strategic leadership and direction of global Quality/Regulatory organization to ensure efficiency and compliance of company products and processes to corporate and global regulatory requirements.
Provide leadership and governance of all activities related to the lifecycle processes of the Quality Management System (QMS), including defining the strategic direction, responsibility, authority, and communication to assure the safe and effective performance of the QMS.
Lead the implementation of strategies to sustain and improve a global Quality organization to support the product lifecycle management from concept to product realization followed by post market surveillance to ensure compliance, growth and sustainability.
Lead a team of seasoned quality professionals in such areas as auditing, complaint handling, corrective and preventive action, document control, engineering, and regulatory.
Collaborate with digital content teams to ensure that content is developed according to geographically-relevant regulations and is appropriately localized based on geographically variable clinical recommendations.
Work with the wider Elsevier business units to ensure that Clinical Risk Management is built into the design and development of new products. This may include support for developing appropriate clinical trials and assessments for new products and actively engaging in developing new collaborations with Academic Health Centers and other academic or clinical entities.
Ensure appropriate reporting and management of clinical incidents, including adverse events, working with Legal and Risk Management.
Build global team including managers and individual contributors, actively working to set & deploy strategy and objectives, promote effective work processes, team building and positive employee inclusion and engagement across all regions.
Ensure staff receive relevant training and development in applicable medical, technical, and regulatory areas specific to their assigned business projects.
Manage all of Elsevier's Regulatory Affairs, providing oversight for all U.S. and international regulatory matters, including filings and interfacing with regulatory authorities.
Work with Technology to assess and deploy safety automation solutions to enhance compliance and drive operational efficiency.
Manage quality and regulatory due diligence to support Mergers and Acquisition activities.
Skills and Abilities
Ability to understand difficult and complex situations and deliver difficult messages in a manner that clearly represents the ecosystem and motivates others to perform under such circumstances
Ability to understand complex global and domestic environments relative to both medical and non-medical software devices.
Significant experience leading business and functional quality teams.
Expertise in QMS development and maintenance such as FDA 21 CFR 820, ISO 13485, ISO 9001, etc.
Experience with risk management (ISO 14971), usability (IEC 62366), corrective action, complaint handling, document and record control, configuration management and control, product realization, and managing outsourced processes, activities, and products.
Experience with developing/sustaining a QMS to support Software as a Medical Device (SaMD) and non-medical software devices.
Experience with data privacy regulations such as HIPAA and EU's General Data Protection Regulation (GDPR).
Practical experience in building and running Quality teams in agile and DevOps models.
Ability to communicate effectively at all levels of the organization with an open, honest and direct communication style.
Ability to thrive and quickly adapt to change; leading others through change in a dynamic, fast-paced industry and work environment.
Experience with incorporating risk-based approaches during product realization and post market release to ensure the safety and performance of the software devices and in meeting applicable regulatory requirements.
Ability to manage a department-wide budget and knowledge of the annual planning process
Ability to travel at least 30% of time.
20+ years in Healthcare industry leading quality/regulatory organizations.
10+ years in software/technology industry.
ASQ quality certificates such as Manager of Quality, Quality Auditor, Software Quality Engineer, Six Sigma Black Belt, etc. are preferred.
Bachelor's in Engineering or Science.
Elsevier is a global information analytics business that helps institutions and professionals progress science, advance healthcare and improve performance for the benefit of humanity. We help researchers make new discoveries, collaborate with their colleagues, and give them the knowledge they need to find funding. We help governments and universities evaluate and improve their research strategies. We help doctors save lives, providing insight for physicians to find the right clinical answers, and we support nurses and other healthcare professionals throughout their careers.
Elsevier provides digital solutions and tools in the areas of strategic research management, R&D performance, clinical decision support, and professional education; including ScienceDirect, Scopus, SciVal, ClinicalKey and Sherpath. Elsevier publishes over 2,500 digitized journals, including The Lancet and Cell, more than 35,000 e-book titles and many iconic reference works, including Gray's Anatomy. Elsevier is part of RELX Group, a global provider of information and analytics for professionals and business customers across industries.
Elsevier employs over 7,000 people in more than 70 offices worldwide. We are an employer of choice, attracting and developing talented and creative people who thrive in a challenging and fast-paced environment. We offer an excellent compensation and benefits package as well as a real opportunity for career growth in a growing organization. Elsevier is an equal opportunity employer: qualified applicants are considered for and treated during employment without regard to race, color, creed, religion, sex, national origin, citizenship status, disability status, protected veteran status, age, marital status, sexual orientation, gender identity, genetic information, or any other characteristic protected by law. If a qualified individual with a disability or disabled veteran needs a reasonable accommodation to use or access our online system, that individual should please contact 1.877.734.1938 or firstname.lastname@example.org.