[Janssen] Controlled Substance Compliance & Security Manager Job

Job description

[Janssen] Controlled Substance Compliance & Security Manager-1500065277WDescriptionJohnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.1. 포지션(Position): Controlled Substance Compliance & Security Manager2. 계열사(Sector): 한국얀센(Janssen)3. 근무지(Location): 경기도 화성시[DESCRIPTION]Responsible for overseeing, monitoring and coordinating all aspects of the controlled substance & listed chemical compliance and security effort for the end to end South Korea supply chain (JSC and CLS); ensures that established controlled substance operational controls, security systems, processes and procedures are in continual compliance with federal and local laws; collaborates with internal stakeholders to successfully resolve compliance issues.[REGULATORY COMPLIANCE RESPONSIBILITIES]Direct all activities to assure flawless compliance with all local and federal regulations regarding the controlled substances handling and security requirements within the site.1. Serve as company liaison with the local government for all Controlled Substance Compliance /Security related issues. Host all Controlled Substance Compliance /Security related Audit and Inspections.2. In coordination with CS Regulatory Compliance ensure the Janssen manufacturing site and CLS facilities are inspection ready for Global Controlled Substance Compliance /Security audits and support external inspections by federal, state and local law enforcement as well as corporate inspections related to Controlled Substance and listed chemicals.3. Develops, maintains and implements site regulatory programs and systems to ensure CS regulatory compliance for end to end supply in South Korea. Actively monitor and assure compliance with country specific requirements for the handling of CS and applicable global standards, global and local SOPs. Assist in the management, development, and implementation of policies and procedures which minimize the exposure to the adverse effects of pharmaceutical diversion. Revise SOPs as per current practices and give training to individuals. Ensure that the procedures described in SOPs are accurate and are being followed.4. Completes or ensure completion of required CS government reporting. Ensure government required data is collected, accurately completed and submitted per government deadlines Sales Reports, Yearend Inventory reports, etc. Continually monitor controlled substance documentation effort, electronic and hardcopy (order forms, purchase orders, transfer documentation, quota certificates, bills of lading, import/export documentation, etc.) ensuring accuracy and compliant recordkeeping and retention.5. Understands the requirements for a suspicious order monitoring program/diversion prevention programs as it pertains to the manufacturing activities supported in the role if required by local government. This may include assisting with setting up a program to monitor tramadol in order to anticipate whether proactive measures are needed to get the site ready should the government schedule this product. Provide guidance to RFID team to ensure project meets government deadlines and expectations.6. Ensures demand information for site is collected for submission to the local government as required. Expedites permitting and other government requests as needed to support changing supply chain conditions.7. Perform proactive contact with the local regulatory agencies, resolving unusual issues, expediting permit requests, obtaining special permission and clarification of requirements.8. Inspect and audit material handling, manufacturing, storage and destruction activities and identify potential compliance gaps as well as drive process changes in order to increase security and compliance. Follow-up on corrective actions, track timely closure of CAPAs and investigations.9. Oversee the coordination of availability of controlled substance materials, anticipate requirements, and reorder in a timely manner to meet developmental and market order needs. Ensures un-interrupted supply of controlled materials (imports, exports, shipments). This involves resolving unusual issues, obtaining special permission and clarification of requirements with the appropriate government agencies. Assures an adequate system is in place to track import/export permits.10. Oversee Inventory Accountability and Reconciliation for all controlled substances. Assure all on-hand controlled substance materials accountability in manufacturing, laboratories and external storage locations (CLS) are maintained and tracked through a readily retrievable inventory system and to monitor throughout the year to ensure preparedness for year-end inventory. Monitors trend and yield analysis for manufacturing audits. Document deviations and investigations through Trackwise. Review and audit Batch Manufacturing and Packaging Documentations for reconciliation purposes.11. Assist in handling and processing of controlled substance Investigational Samples and return goods from customer. Ensure government approved disposal practices are in place.12. Oversees the site security force partnering with the onsite account manager to ensure security requirements are met. Reviews and develops local security procedures
- ensures compliance to procedures Ensure security assets are maintained and critical equipment failure immediately addressed by facilities and maintenance security personnel. Reviews maintenance requirements for security equipment. Conducts investigations and follow-ups on events utilizing ets Trackwise. In partnership with Facilities and Engineering, prepares local operating and capital budgets for security13. Conducts security reviews and evaluations including contract manufacturing locations. Proficient with handling local inspections around site security systems. Supports local security requirements.14. Audits carriers (assures audits take place as indicated) and ensures appropriate security requirements are met for any movement of controlled substances at either sites (import, export, inter-company and customer shipments). Assist other JSC sites as needed.15. Develop and grow a Security culture among the employees and contractors. Training includes developing strong DEA coordinators in the following areas: Warehouse, Shipping & Receiving, QC and Logistics.[ESSENTIAL DUTIES]1. Ensure site registration requirements to handle CS (for example government and local licenses) are submitted per schedule and government approval is received to handle CS at both JSC and CLS sites.2. Ensure sites are inspection ready for local regulatory. Lead field visits as needed. Ensure timely communication to the districts on any material losses or diversions. Lead any potential diversion investigations in partnership with J&J Global Security. Participates or leads internal audits of JSC/CLS sites regarding CS Compliance.3. Assures an employee screening process is in place and monitors for compliance. Address adverse finding events.4. Performs or ensures physical counting/reconciliation per schedule as required by local authorities. Address discrepancies, report out results.5. Responsible for ensuring site compliance training is performed for all employees at site level. This training includes developing strong CSC SMEs/coordinators in the following areas: Warehouse, QC and R&D. Lead Controlled Substance Compliance /Security training development for direct reports and JSC and CLS site personnel.6. Ensure deviations, incidents regarding controlled drug are entered into ets Trackwise and ensure proper follow up is done on the corrective action.7. Ensure timely compliance metric reporting. Provide and present input to quarterly management review.8. Understands the local requirements for quota, permits and estimates impact on planning processes. Understands production planning/materials management processes. Ensure proper documentation is completed for each movement per local regulations. Ensure timely submission of permit requests to support import/export demand. Ensure timely supply chain metric reporting. Be capable of reporting out at S&OP meetings regarding supply.9. Oversee coordination regarding the shipping and receiving of controlled substance products and materials, check that method of shipment meets customer satisfaction, government regulations and protect product quality.10. Will function in a supervisory role to several individuals including Security Associates and Controlled Substance Compliance SMEs in QC, Production and Warehouse.11. Oversees the electronic security systems to insure effective access control by means of card access system, closed-circuit television & alarm systems, and other appropriate types of electronic security systems in alignment with CS Compliance & Global Security Goals and Objectives.12. Ensure proper evaluation and selection process for guard services is performed that allows the Company to have an appropriate level of security providers, through a continued monitoring of services.13. Ensure security investigations related to thefts, counterfeit or diverted products, workplace violence, or other incidents always following Global Security and Controlled Substance Compliance guidance are performed. Communicate incidents following site escalation SOPs in a timely manner and ensure appropriate communication to the local authorities on any control substances material losses or diversions.[INTERPERSONAL CONTACTS](Type / Reason for Contact / Frequency)Internal ContactsSite’s Managing Director / Inform, procure support, request resources / On goingSite Leadership Team / Share information, enable implementation of programs, procure support / As neededGlobal Security / Inform, procure support, request resources and ongoing guidance and coaching on specific issues. / On goingControlled Substances Compliance / Share information, procure support, partner for the implementation of programs and assure compliance with Controlled substances regulations. / On GoingSecurity Staff / Supervise, provide guidance and instructions, and insure consistent and efficient services. / DailyExternal to JNJRegulatory agencies / Network, gather information, keep up to date on regulatory changes and procure support on specific assignments from Senior Compliance Manager and/or the Site General Manager. / As neededVendors and security field peers / Gather information, keep abreast of tendencies, create network. / As needed[REQUIREMENTS]EDUCATION AND/OR EXPERIENCE:Bachelor’s Degree or equivalent education and experience with controlled substance compliance management in a regulated environment. Experience Required: 3 years in a the pharmaceutical industry, criminal justice/law enforcement or related fieldsExperience Preferred: 5 years in the pharmaceutical industry, law enforcement, or supply chain with emphasis on controlled substance handling and compliance. Fully Bilingual (English/Korean) is required. The selected candidate must be able to travel 25% of his/her time.
COGNITIVE SKILLS:The person must have the ability to collaborate across functions and geographies. The person must be confident and mature with the ability to connect, inspire and influence others without direct reporting relationships. Interpersonal communication and presentation skills, capable to be aware, calculate, catalog, compare, classify, coordinate, copy, detect, diagnose, edit, estimate, evaluate, influence, inspect, interpret, read, observe, plan, collect and organize. Ability to work under time pressure and customer services oriented.
EQUIPMENT, TOOLS, MACHINERY AND MATERIALS:MS Office suite of software, automobile, general office material, telephone, cellular phone, manuals, catalogs, filing system, manual tools and calculator.
OTHER REQUIREMENTS:Willing to travel as necessary or required, which may include overnight and/or weekend travel within Korea, Japan and US. Available to work extended hours. Available to provide on call support after working hours.
Qualificationssee abovePrimary Location:Asia Pacific-South Korea-Gyeonggi-do-Hwaseong-siOrganization: Janssen Korea, Ltd. (7220)Job Function: Regulatory Compliance