Summary: Accountable to administrate the operation systems such as: training/qualification program, tier-management meetings, OPEX initiatives (Ex. 5s, cycle time reduction), EBR and Batch Record review cycle, recognition program, among others to assure manufacturing/packaging processes are executed during first/second/third shift, as applicable, for B41/B6/B37 to ensure high quality pharmaceutical end products. Perform Gemba Quality walkdowns and manages close-out of generated actions. This position must comply with all Security guidelines, Environmental Health and Safety regulations, regulatory/compliance requirements, and the current Good Manufacturing Practices related to the job function. Responsibilities: 1. Lead/Administrate, monitor and improve the operation systems as Manufacturing Production area Team to ensure that production, competitive cost, quality/regulatory, customer service requirements are met or exceeded. 2. Leads, monitor systems such as: training/qualification program, tier-management meetings, OPEX initiatives (Ex. 5s, cycle time reduction), Electronic Batch Record and Batch Record review cycle 3. Champion of the recognition program. 4. Plans and organizes the area work to achieve a High Performing Team environment. 5. Manages with SAP coordinator the Inventory SAP/SYNCADE transactions. 6. Manages audit readiness plans as well as, level 3 investigations. 7. Is the liaison for the operations start up for shutdowns, as well as, the liaison with the facilities team to assure manufacturing buildings are at optimum conditions. 8. Manages the assigned operations area people staffing, performance assessment, merit increase /annual performance bonus, counseling/coaching/disciplinary & corrective actions, and takes action for performance improvement as well as career development. 9. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). 10. Assures a streamlined and continuous process flow of Manufacturing Operations area. 11. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. 12. Determines production schedule, updates schedule’s board, communicates daily schedule performance to team members and communicates the shift production information with other shifts leaders. 13. Reduces cycle times and optimizes production scheduling by the use of innovation tools including. 14. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. This is intended to be a general job description and should not be construed as all inclusive. 15. Trains the Team on any necessary compliance and quality requirements related with the area or the business. 16. Collaborates effectively with other functional SMEs to ensure production goals are met and investigations are expeditiously completed. 17. Participates/leads in and may lead continuous improvement initiatives applying tools like: 5S, LEAN manufacturing and Six Sigma to improve quality, cost, safety and cycle time. 18. Performs administrative duties for the assigned area that include team members attendance monitoring, attendance timecards approval, vacations scheduling and approval and overtime coordination to meet production requirements. 19. Provides, in coordination with other departments, the guidance and resources to support technology transfer activities, equipment qualification, process validation, troubleshooting, clinical lots production, and process optimization. 20. Participates in quality and safety investigations. 21. Provides support to the regulatory affair reports, customer complaints, and area exception reports (e.g., Quality Investigation Reports, Quality Complimentary Reports, Change Request Forms, etc.). 22. Ensures that area Team members comply with the established learning curriculum to achieve proper knowledge transfer/acquisition. 23. Participates actively as a key contact member of the OSD operations areas in the internal and external audits. 24. Provides input in the creation and revision of SOP’s, protocols, batch records and related documents to assure compliance with cGMP’s, company policies / procedures and documentation practices. 25. Serves as the back-up of the OSD Operations Manufacturing Manager, as requested. 26. Maintains accurate tracking records and provides timely feedback to Manager regarding status of assigned area/tasks. 27. Monitors usage and expenses related to supplies and labor costs in the work area. 28. Promotes and models the BMS Core Behaviors, facilitating teamwork, providing coaching and feedback. Knowledge/Skills: • BS Degree in Engineering /Biology/ Chemistry, Pharmacy or related sciences with three (5) years of experience in pharmaceutical OSD manufacturing processes; or BBA Degree in Business Administration with five (5) years of experience in pharmaceutical OSD manufacturing processes. • Proven in-depth knowledge on Oral Solid Dosage Manufacturing processes • Proficient in regulatory / compliance areas of cGMPs, FDA regulations, EHS • Basic understanding of product cost structure, budgeting process and spending • Preferable to have three (3) years of experience in a supervisory / managerial position, • Preferable to have one (1) year experience in a very highly automated manufacturing operations environment (Electronic Batch Records/NIR-PAT Technology) • Proven strong leadership skills managing performance to the attainment of high performing team • Knowledge and experience implementing Six Sigma and Lean Manufacturing • Strong business sense • Sense of urgency, accountability and agile decision making. • Understanding of and capability to support financial and total quality/safety objectives • Assertiveness and uncompromising attitude with regard to the quality standards • Strong interpersonal and teamwork skills • Ability to develop and maintain effective professional relations with colleagues at all levels across the organization; • Ability to integrate actions toward objectives. • Excellent and effective communication skills in both English and Spanish • Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary
