At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Business Process Quality **Job Category:** People Leader **All Job Posting Locations:** BE009 Turnhoutseweg 30, CH024 ACT Allschwil, Switzerland, GB006 High Wycombe, US010 PA Horsham - 800/850 Ridgeview Dr, US159 NJ Titusville - 1125 Trenton-Harbourton Rd **Job Description:** Job Description Johnson & Johnson is recruiting for a Director, Process & Personnel Qualification Management Lead located in Titusville, NJ, Horsham, PA, Beerse, Belgium, High Wycombe, UK, or Allschwil, Switzerland. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): + US - Requisition Number: R-000068 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. R&D Quality is responsible for Quality and Compliance Oversight and related Risk Management for the Research and Development organization. In that perspective, R&D Quality is intensively collaborating with key partners including the Therapeutic Areas, Global Development, Global Regulatory Affairs, and the Global Medical Organization along the development process, from discovery, pre-clinical, clinical, launch to post-approval activities. The services and deliverables which R&D Quality provides to its key partners are the collaborative output of the different vertical organizational teams and are the result of interactions and partnership at different levels in the organization. The Process and Data Management team is one of these vertical organizational teams, responsible for providing compliant, easy accessible process content, and for making learning tailored to the moment-of-need and at the point-of-use. As Process & Personnel Qualification Management Lead, you will lead a global team of Process & Personnel Qualification Management experts (PPQM experts) overseeing the end-to-end delivery of process, qualification and training in the R&D Quality supported Quality Management System (QMS) framework, enabling dedicated Business Partners to conduct R&D/Medical Safety in an efficient and compliant way, resulting in programs that allow for seamless registration of the J&J innovative products. The role will be setting the vision and strategy for process and personnel qualification management in collaboration with senior leaders in R&D functions. The Director Process & Personnel Qualification Management (PPQM Lead) is a Leadership Team (LT) member of the Process and Data Management (PDM) department in R&D Quality. This role serves as a single point of contact for senior management with business partners where the PPQM Lead is responsible for roll out and training of the overall applicable quality framework. As an owner of the E2E procedural framework they are responsible for overall development of the PPQM strategy and ensuring Quality-by-Design principles are instigated in all PPQM deliverables. The PPQM Lead is a member of the PDM LT and will collaborate with the other PPQM Leads of business units, PDM Head and other positions in R&D Quality to ensure an efficient and compliant QMS is delivered. The PPQM Lead plays a strategic and operational role in coordinating the work of the PPQM team in a respective business unit. Where applicable, they will work in close collaboration with the business partners managing the delivery of the end-to-end connected business processes, applicable documentation and supportive training to implement quality procedural content and personnel qualification programs supporting the business partner objectives. The PPQM Lead manages staff for process/qualification/training design and keeps abreast of all PPQM needs, new materials, methods and digital/data science and automation techniques tailored to the business needs. As department head, the PPQM Lead must develop functional programs for PPQM staff and identify developmental needs including preparing personnel for more responsible positions and increasing effectiveness in present assignments. Key responsibilities: • Map, analyze, develop, and implement compliant and efficient end-to-end processes and related training and qualification as part of the GxP Quality Management Framework • Represent R&D Quality/PDM and serve as a champion to key (pre)clinical, Medical Safety, Therapeutic Area and other business partners and stakeholders. Conduit between business partners, quality groups and governance to ensure the GxP Quality Framework evolves with the business and regulatory requirements and needs, including changes, CAPA, investigational/inspectional requests. • Implementation of the transformation roadmap of R&D Quality/PDM towards data-centric content and qualification management, and the internal first-time-right end-to-end process from request to effective process/qualification material. • Lead and manage a team of PPQM Experts Additional responsibilities • R&D Quality – Quality Connect Cornerstone Workstreams: Championing of the Cornerstone Workstream Leads and Teams in defining, deploying and sustaining the workstream plans and programs as they related to partnership with its key partners. Other responsibilities • Leadership or support of projects, meetings, etc. as directed by the Head of R&D Quality/Head of Process and Data Management. Independence/Autonomy • This leader will act independently and with high impact to drive results and organizational performance. They will seek guidance only as needed on new assignments and understand the sense of urgency related to activities. They will develop and implement strategies related to job description core areas. • The leader is expected to lead and be proactive in setting priorities to achieve R&D Quality goals and objectives. Qualifications Education: • Master’s degree in Science or Business preferred, Bachelor’s degree required • Required Years of Related Experience: A minimum of 12 years’ experience in a medium to large scale matrix organization, including a minimum of 10 years of experience in a pharmaceutical/device compliance-related field and/or equivalent time and experience in a related healthcare R&D area is required. • A minimum of 5 years’ experience in the field of process design, training design or related field is required. Required Knowledge, Skills and Abilities: • The ability to communicate well, both in oral and written form (in English) and using a variety of media, is required. • Demonstrated competencies include industriousness, self-awareness, adaptability, attention to detail and a high capacity for teamwork. Is required. • The role requires strong knowledge of worldwide (pre)clinical safety compliance regulations and guidelines, along with broad exposure to the array of regulatory and legal requirements within the life science industry. • Working conditions require resolution of complex problems within tight timelines. • This leader will be responsible for making decisions regarding business issues, strategic support, and organizational development, as required by business urgency and organizational growth. The scope is across R&D Quality, the Janssen R&D Therapeutic Areas, and various R&D / Medical Safety functions, and requires significant collaboration, alignment and influencing. Leadership experience and skills: • Strong personal leadership with demonstrated competency interfacing with senior leaders • Strong networking and relationship-building skills • A proven track record of leading and developing people in a matrixed organizational set-up • Strong organizational and people change leadership and management skills • Ability to create an open and inviting environment • Ability to embrace generational differences • Ability to operate in a virtual environment • Proven business acumen • Strong understanding of the digital and data science landscape • Exceptional written and verbal communication skills • Technology experience and skills: • Proficiency with MS Office products (Word, Excel, PowerPoint, Outlook) • Proficiency with Project Management software Other: This position may require up to 15% domestic or international travel.