At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Accountable for the execution of the Compliance and Simplification strategies for the Manufacturing Operations at Building 41, 37 and/or Building 6. This includes Right First Time improvement plans, compliance remediation activities and its implementation, in addition to the simplification strategies for operational systems such as cycle time, batch records and electronic batch records. Will be responsible of the design and implementation of the manufacturing improvement plans to ensure its effectiveness by conducting and prioritizing the activities to meet on time completion delivering the expected results. This position must comply with all security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.MAJOR DUTIES AND RESPONSIBILITIES:1. Executes the Compliance Strategy Teams for B41, B37 and/or B6 to improve the Right First Time.2. Support CAPAs effectiveness evaluation when needed.3. Support internal/external Regulatory Audits as Manufacturing processes and Manufacturing Technology experts.4. Generates applicable change Controls.5. Will work closely with functional areas such as Manufacturing Technoloy, OPEX and Quality for the implementation of improvements to the manufacturing processes and cleaning programs, compliance improvements and documentation simplification (electronically/paper) considering Compliance guidelines, Operational Excellence (OpEx) and MES (Syncade).6. Leads and drives multifunctional teams that will have dotted line responsibilities to this role7. Plans will be generated and implemented based upon impact to Humacao strategy goals and objectives to ensure that objectives are being executed under the BMS standards, procedures and policies in order to improve quality, reduce cost, increase productivity and improve product cycle time.8. Will be the Manufacturing Liasion for assignable projects to assure operational readiness.9. Develops and coordinates the performance excellence / performance improvement vision and deployment planning as defined by the Manufacturing Department Team.10. Gathers and evaluates data to reduce waste and variability in the current process such as product cycle time optimization.11. Targets the completion of process improvement projects within specified timeline while achieving cost reduction goal.12. Leads the applicable Operations meetings, gather requirements and provide daily status reports of corresponding operations. transfer and qualification such as, but not limited to Manufacturing Technologies.13. Supports productivity initiative programs by identifying efficiencies in the operational areas and providing resources to support productivity teams.14. Creates team processes for optimizing results and leads actively and provides contributions after key projects have been identified.15. Provides management with project status updates, feedback and appropriate reporting on key responsibilities and objectives.16. Works directly with the other Manufacturing Operations area leaders to assure successful implementation of changes/initiatives on hand.17. Promotes and model the BMS Core Behaviors, facilitating teamwork, providing coaching and feedback, as needed18. Coordinates communication activities and market the process and results by publishing goals, plans, progress and results.19. Enforces critical thinking specifically during scope, problem statement, analysis tools, risk assessment evaluation and milestones determination to guarantee that opportunities are properly addressed.20. Participates actively in the preparation of the department budget and effectively manages company funds and active21. Provides support to the regulatory affair reports, customer complaints, and area exception reports (e.g., Quality Investigation Reports, Quality Complimentary Reports, Change Request Forms22. Keep dashboard, monitors, evaluates and communicates area performance metrics for processes, cost and quality control.23. Supports all site Initiatives and any other assignments based on business needs.24. Serves as the back up in the absence of the OSD Manufacturing Process Improver Associate Director.KNOWLEDGE / SKILLS: BS Degree in Chemistry, Biology, Mechanical or Chemical Engineering or Pharmacy or related science with five (5) years of direct (leading, developing, executing) experience in pharmaceutical OSD manufacturing processes; or BBA Degree in Business Administration or other Engineer degree with at least seven (7) years of direct (leading, developing, executing) experience in pharmaceutical OSD manufacturing processes. Within the experience, preferable to have two 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) Proficient in regulatory / compliance areas of cGMPs, FDA regulations, EHS Basic understanding of product cost structure, budgeting process and spending Knowledge of Six Sigma, Lean Manufacturing, Project Management is highly desirable. Proven strong leadership skills while maintaining effective communication and interactions with superiors and colleagues. Team oriented with excellent interpersonal skills. Strong business sense; understanding of and capability to support both financial and total quality objectives. Assertiveness and uncompromising attitude with regard to the quality standards applied in the day-to day activities. Ability to leverage both internal and external resources from various levels. Proficient in regulatory / compliance areas of cGMPs, FDA regulations, EHS. 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. Experience in writing technical reports, executive summary type presentations to senior management and technically detailed presentations to specialized technical groups such as Technical Services, Supply Chain, Engineering and QC/QA.Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal pany:Bristol Myers SquibbReq Number:R1534955-en-usUpdated:2021-02-23 17:45:39.103 UTCLocation:Humacao, PRBristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
