Company Profile:

: Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We welcome innovation—bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make every single day a little better. Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives. In India, J&J operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices, which are independently handled and report into their respective Global business segments

Job description:

SECTION 1: JOB SUMMARY*

Assistant Manager Design Quality adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously and in the solution of technical and related projects.  Work is generally expected to result in the development of new or refined methods to reduce risk, equipment, materials, processes, products and or technical methods.

He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. 

SECTION 2: DUTIES & RESPONSIBILITIES*

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

1. 1. Ensure compliance of Quality Make operations with applicable regulations and policies including local and international standards.
   2. Improve overall efficiency of the Quality Make through use of Process Excellence, Lean principles, and Data analysis.
   3. Review and approval of validation documents for manufacturing, utilities / facilities, and microbiology functions.
   4. Support NCR / CAPA/ Complaints/ Internal Audit/ External Audit process.
   5. Support the Quality Systems used to improve product quality, process and customer satisfaction
   6. Mentor, train and supervise the Quality Make staff.
   7. Make recommendations to management regarding ways to improve Quality and Manufacturing processes in support of current requirements of Good Manufacturing Practices.
   8. Provide inputs for annual business (budget) planning process.
   9. Utilize cost control initiatives to reduce expenses.
   10. Responsible for communicating business related issues or opportunities to next management level
   11. Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
   12. Review/analyze whether current product and processes (including actions or decisions conducted) are complying to standards ISO 13485 and other applicable regulations / standards.
   13. Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges. 
   14. Supports the development of quality strategies related to the transfer of products, materials, and components within J&J or externally.  Supports new product / process / equipment introduction as part of design transfer.
   15. Performs other duties assigned as needed.
   16. Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints.  Escalation of quality issues as appropriate.
   17. Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.
   18. Approve IQ, OQ, PQ, TMV or Software Validation.
   19. Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
   20. Ensure that customer CTQs are known and adequately addressed in control plan.
   21. Develop measurement systems/capabilities, destructive tests, non-destructive tests for new product / process, if any.
   22. Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls etc. for new product / process.
   23. Develop, interpret, and implement appropriate process monitoring and control methods consistent with the level of process/product risk for new product/process.
   24. Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard / regulation.
   25. Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
   26. Conduct strategic planning with site leaders.  Partnership with other functions to establish business priorities and resource allocation
   27. Ensures effective quality strategies are created for the validation of test methods, process and design of new product / process. 
   28. Shall act as backup for Change Management, Complaint Management, Periodic Validation, QSMR and IPQA processes.
   29. Responsible for communicating business related issues or opportunities to next management level.
   30. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
   31. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
   32. Performs other duties assigned as needed.

 

 

SECTION 3: EXPERIENCE AND EDUCATION*

• A minimum of a bachelor’s degree, preferably in Pharmacy or related technical field. Generally, requires 10-12 years of related experience. 
• Experience working in both an FDA and regulatory environment is preferred.
• This position will require relevant experience working in manufacturing/operations. 

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc. 
• Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
• The ability to perform "hands on" troubleshooting and problem solving is preferred.  The ability to think on the feet and providing sound judgment is highly desired.
• Good technical understanding of manufacturing equipment and processes is required.
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred