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:** Supplier Quality **Job Category:** People Leader **All Job Posting Locations:** Shizuoka, Japan **Job Description:** **Key Responsibilities:** + Manage analyst schedule to support Product Release and Environmental Monitoring activities + Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards + Review/approve documents as a QC department subject matter expert (SME) + Oversee timely completion of laboratory investigation of OOS/ invalid assays, CAPAs and change controls + Ensure accuracy and completeness of executed analytical method transfer activities + Set testing priorities and manage work assignments + Maintain individual training completion in a compliant state + Mentor, train and supervise quality control staff + Evaluate performance and provides opportunities for growth. + Support internal and Health Authority audits + Support audit related investigations **Qualifications** **Education:** + A minimum of a Bachelor’s degree or University equivalent in Scientific discipline is required. Major in Biology, Microbiology and Chemical is preferred. **Experience and Skills:** **Required:** + A minimum of 4 years of experience in a regulated manufacturing industry. + A minimum of 4 years working in a Supervisory role in a laboratory. + Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or system + Experience with Nonconformance, CAPA, Audit Observations, and initiates and maintains interplant communications of quality issues. + Prior People Leader experience. + Advanced Business English proficiency **Preferred:** + Experience with LIMs and SAP or equivalent systems + Detailed knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards for QC testing + Japanese knowledge ======================================================== 社内公募ガイドライン + 経験値により採用するポジションタイトルが異なります。 + 応募の際はAskGS内の社内公募ガイドラインをご一読いただき、応募ください。１８か月未満の方は応募前に上長及び担当BUHRの許可を取ってから応募ください。複数同時応募不可になります。 + 在籍期間に関わらず、書類選考を通して１次面接に進んだ場合は、社内公募に応募し選考に進むことを上司に報告してください。 + 社内紹介を行う場合は、Career Hub上の“社内紹介制度の概要”の詳細を理解した上で、コンプライアンスを守って紹介したものとみなします。