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:** Quality Assurance **Job Category:** People Leader **All Job Posting Locations:** Incheon, Korea, Republic of, Seoul, Korea, Republic of **Job Description:** **About Innovative Medicine** Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Johnson & Johnson Innovative Medicines (IM) is looking for a Quality Leader APAC region. **Position Summary:** The Quality leader is accountable for the quality of supply of new and commercial biotherapeutic products manufactured in the region. As the virtual site quality head this role leads strategic CMO(s) to ensure reliable supply, provide the highest quality standards at optimal total cost and achieves maximum relationship value through innovation, continuous improvement and collaboration with the CMO team(s). **Key Responsibilities** : + Directs all the Quality and Compliance activities related to CMO manufacturing site, to assure flawless qualification, tech transfers and supply for commercial batches in compliance with local regulatory, J&J Innovative Medicine (JJIM) corporate guidelines and cGMP + Serve as the primary point of contact for the CMO team and Johnson & Johnson's technical partners, including MSAT, R&D, and IMRC. Foster robust partnerships with CMOs by establishing and maintaining effective communication channels. + Leads and develops a team of professionals to ensure strong results through effective performance management and development planning. Deploys people at their strengths and coach them to be at their best. + Always ensures inspection readiness of the CMO for both announced and unannounced inspections through extensive interaction with CMO leadership, performing Gemba walks, managing issue resolution, and implementing and documenting the right corrective actions in a timely manner. + Escalates issues as appropriate to Senior Management and supports the Executive Management Reviews. Provides regular progress update to Senior Management as applicable. + Monitors trends, identify issues, recommend, and implement appropriate actions. + Investigates customer product quality complaints + Demonstrates ability to operate with minimal supervision and accountability to lead resolution of complex quality and compliance issues + Leads and contributes to External Quality improvement projects **Minimum Qualification** + Minimally Master’s degree is required; other advanced degree is preferred. + A minimum of 10 years of experience in E2E Pharma manufacturing (preferably in biotherapeutics drug substance and drug product) of which at least 5+ years of People management experience. + Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers. + In depth knowledge of global cGMP requirements and ISO requirements is required + Excellent analytical skills to identify gaps and root causes of issues and think out of the box to develop a solution. + Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude. **Other requirements:** + The incumbent must work at the CMO site on a routine basis (±60%) – with a target to be 3 days/week on-site + Strong ability to manage problems and urgencies during issue management + Ability to work virtually connecting with other sites, customers and global functions Work Environment: At Johnson & Johnson IM, we embrace a hybrid work model that effectively balances the advantages of in-office collaboration with the flexibility of remote work. For this role, you are expected to work on-site a minimum of 3 days per week. This on-site presence is vital for fostering collaboration and engaging with cross-functional teams, ensuring that quality remains at the forefront of our operations. The remaining days of the week may be reserved for remote work, providing flexibility while allowing for team interaction. **Legal Entity** Janssen Vaccines **Job Type** Regular **Application Documents** Free-form resume AND cover letter is preferred (in Korean or English). **Application Deadline** Open until the position is filled. **Notes** + Preference will be given to individuals subject to national veterans’ benefits and persons with disabilities upon submission of relevant documents as per applicable laws. + Only candidates who pass the resume screening will be notified individually. However, notifications may be delayed due to company circumstances. + If any false information is found in the application documents, the hiring may be canceled even after the offer is confirmed, and future applications may be restricted. + Submitted documents will not be returned and will be deleted upon request.