The group manager has overall responsibility for successful execution of local procedure document management and implementation of global procedure document including training assignments in Janssen Japan R&D, providing oversight and leadership to SOP Management group.
All aspects of procedure document management must be high quality, meeting all the J&J requirements and Japan regulatory mandates.
The group manager will also lead initiatives with the other quality functions and relevant business partners to enhance knowledge and promote compliance with company standards, global regulations and guidelines, and current expectations of regulatory authorities. In addition, he/she provides leadership in ensuring global compliance is a key focus and strives to maintain and improve quality in R&D Janssen Japan.
Group Management and Oversight:
・ Leads SOP Management Group, Quality and Compliance Management, and be responsible for the end-toend group activities according to internal requirements and related regulations.
・ Develop strong working relationships with key business partners, and create a culture of cross-functional collaboration across relevant teams
・Ensure appropriately life cycle management of Procedural Documents; the Quality Review for Local Procedural documents and Implementation Assessment for Global procedural documents by group members.
・Supports Director, Quality and Compliance Management the success of the long-term departmental quality strategic plans through effective partnering with key stakeholders across Janssen Japan R&D and the other quality functions.
Training & Development:
・ Identifies training needs. Develops training and development strategies for the team to be able to support GxP compliance activities of departmental scope, collaborating within the department and with the business as required to ensure required skills are available to execute the group activities.
・ Provides career guidance and ensures development plans are in place for direct reports. Ensures that each team member is knowledgeable about compliance in the assigned tasks.
・ Proactively and independently coaches and mentors others to support talent development and training to meet current and future business needs. Develops or is involved in the review and approval of training curriculum as applicable to an area of expertise.
・ Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.
・ Actively monitors staff skillsets and recommends actions to ensure the organization can support business objectives and maintain global alignment.
・ Directly responsible and accountable for the supervision and development of direct reports.
・ Drives and implements talent strategies in a standard, fair and transparent approach to ensure audit skills remain current to support business objectives.
・ Promotes a fair framework of recognition and reward, a mature sense of discipline, open communication, and mutual respect.
・ Fosters an environment which encourages the company’s Credo commitment to equal employment opportunity and the value of a diverse workforce.
・ Takes an active role in, and leads, projects and teams in key project initiatives across the organization or company. Influences stakeholders and determines priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress. Effectively drives projects to completion.
・ Applies risk evaluation and knowledge management strategies into the day to day activities and acts as a change agent shaping the environment and ensuring global alignment and harmonization.
・ Promotes a working environment that challenges the status quo, and leads and adapts to change, creating a positive culture.
・ Leads or supports projects, meetings, etc. as directed by the Director, Quality and Compliance Management including but not limited to process improvement, inspection readiness, and remediation.
・ Minimum of 10 years of previous Pharmaceutical Industry experience in R&D and/or quality and compliance area, or equivalent level of expertise and the experience.
・ Thorough knowledge of the drug development process, good knowledge of related international/local regulations, GCP/GPSP/GVP/GLP/GMP/GDP compliance regulations (scope is only clinical part for GMP and GDP).
・ Experience in R&D process management to successfully drive departmental productivity, strategy optimization, process improvements and efficiencies
・ People management experience preferred
・ Ability to interpret data for developing action plans to improve business/performance.
- Logical thinking and problem-solving skills.
・ Good conflict handling/resolution and negotiation skills
・ Project management: Ability to independently plan, organize, co-ordinate, manage, lead and execute projects/assigned tasks
・ Excellent communicator, with excellent interpersonal skills and diplomacy
・ Able to create win-win situations with internal and external partners
・ Ability to apply knowledge of the ICH Guidelines; must be familiar with Japanese regulations (not only the Pharmaceutical Affairs Act but other regulations that govern clinical trials), FDA regulations, and the EU Clinical Trial Directive and regulations, as applicable
・ Proficiency in English (both oral and written)
A Bachelor of Science (BSc), Arts (BA), or equivalent degree
Janssen Pharmaceutical K.K. (7195)