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:** Legal & Compliance **Job Sub** **Function:** Enterprise Compliance **Job Category:** Professional **All Job Posting Locations:** Incheon, 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 Janssen Vaccines Corp. is recruiting for a Senior Compliance Specialist, located in Incheon, South Korea. **Key Responsibilities:** Execute internal audit program at the pharmaceutical manufacturing sites. Prepare and manage external GMP audits and inspections (e.g. Health Authority, Customer, ERC, etc). Provide compliance subject matter expertise to the manufacturing sites and site-based projects. Deploy compliance initiatives for the site in alignment with Innovative Medicine Regulatory Compliance. **Site internal audit program:** + Execute internal audits (schedule, issue agenda, prepare, conduct audit, issue report) + Evaluating responses to internal audits + Enter data into the quality system (COMET) **Execute compliance walkthroughs Facilitate and/or support external GMP audits and inspections (Health Authority, Customer). Including:** + Inspection Readiness (audit preparation, schedule and manage mock inspections, SME coaching) + Partner with Quality to run inspections (host and/or coordinate front room and back room, as well as providing daily inspection summaries) + Review site response and associated CAPA for Health Authority inspections + Provide input to daily inspection summaries, as needed **Support identification of changes in regulations and gap assessments related to compliance procedures:** + Identify changes in regulations that impact compliance procedure, perform gap analysis against current practices + Implement J&J Compliance Standards (e.g. Audit/Inspection Mgt) and partner with sites on J&J standard implementation **Participate on project teams, as requested:** + Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality System and/or projects. Review complaints and field actions as needed + Represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance meetings, etc. + Partner with site for execution of proactive compliance scans + Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Mgt, etc.) to proactively identify risks and drive compliance improvement across the site **Regulatory compliance documentation and remediation plans:** + Receive regulatory compliance requests, reviews and provide applicable documentation to accurately address the request and deliver documents to the requested in the agreed due date + Track regulatory requests until final completion and closure + Prepare GMP statements and responses to questionnaires for the facility or applicable product, as required + Assure regulatory documents are archived + Support organization in preparation compliance metrics, dashboards, preparation of Site Mgt reviews, etc. + As applicable, monitor progress of site compliance remediation plans (e.g. MCAP, SDCAP, etc.) + Collaborate with other groups in IMRC and JJRC to support execution of independent audits and special assessment. Support site during ERC audits (e.g. document review, front/back-room support, site response and associated CAPA review/input) + Ensure timely and accurate reporting of compliance metrics + Coordinate and/or conduct trainings associated with compliance including new hire orientation training **Other duties:** + Connect with external groups (e.g. PDA, ISPE, etc.) to benchmark industry standards + As needed, co-author, review and revise compliance procedures + As needed, review (not approve) significant manufacturing and laboratory investigations, confirmed complaints and S1/S2 Field Actions _Travel is possible (10-15%)_ **Qualifications** **Education:** + Bachelor’s Degree from University or equivalent in Pharmacy, Life Science or Engineering related to pharmaceutical or bio-pharmaceutical technology **Experience and Skills:** **Required:** + More than 5 years of experience in a GMP-regulated industry, and at least 1 year of regulatory compliance experience + Knowledge and experience in GxP and quality systems, FDA/EU regulations & guidance related to bio pharmaceutical manufacturing, and health authority inspections and audits + Strong analytical skills. Ability to clearly articulate issues + Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance community + Delivers on commitment timelines and has high sense of urgency + Experience preparing for inspections, managing inspections and/or supporting inspections **Preferred:** + QA/RA certification is preferred + Experience performing internal or external audits is strongly preferred + Experience in change management and project management + Good verbal and written communication skills in English/Korean, facilitation, and presentation skills. + Good technical writing skills with solid understanding and skills of MS-office (Word processing, presentation, spreadsheet, and database) + Ability to work independently and to effectively interact with various levels + Ability to identify opportunities for improvement **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.