Senior Executive Quality Control

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale and experience to reimagine the way healthcare is delivered and help people live longer, healthier lives.
In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, vision and interventional solutions with the big ideas of others to design and deliver physician and patient-centric products and solutions.
As pioneers in medical devices, we continually focus on elevating the standard of care—working to expand patient access, improve outcomes, reduce health system costs and drive value. We create smart, people-centered healthcare to help the patients we serve recover faster and live longer and more vibrantly.

• The Supervisor is responsible for the day to day management of the quality laboratory. The supervisor will assign and direct staff to ensure that product testing is completed in a timely and compliant manner. The supervisor is responsible for working with staff to troubleshoot instrument issues, investigate nonconforming data as well as review and issue Certificates of Analysis as required. In addition, the supervisor is responsible for collecting, collating and documenting laboratory metrics for presentation to management.
• Plans, coordinates, and direct Quality control activities to ensure continuous production of products consistent with established quality & regulatory standards by performing the assigned duties and responsibilities to support manufacturing and timely delivery of product to customers.

• Managing laboratory testing of Raw material, Packing Material, Finished Product, Stability, Microbiology and In- Process Materials in support of the manufacturing schedule and to ensure timely delivery of product to customers.
• Ensuring that all laboratory test methods and procedures are executed in compliance with specifications and standards. Additionally, working in the development, writing, updating and review of test methods, SOPs, protocols, and specifications as required.
• Serving as Subject Matter Expert for testing methodology. Using knowledge of scientific techniques to independently troubleshoot product quality issues of a complex nature with a sense of urgency.
• Ensuring that all laboratory instruments and systems and software are maintained in accordance with procedures and standards.
• Ensuring that all laboratory activities are conducted in accordance with government regulations and safety requirements as well as all Enterprise, Sector and Company policies.
• Review and approve reports of Finished/Raw material/Packing material/Stability and quality records (e.g. non-conformance, CAPA, lab incident, log book etc.) related to laboratory events.
• Driving the investigation of non-conforming laboratory test results as well as reviewing and approving laboratory OOS and OOT events including related quality records and investigation reports. This will include ensuring that the reports are consistent, complete and in alignment with applicable standards and procedures including appropriate content and references.
• Escalating quality issues to management
• Monitoring laboratory quality data and metrics on a regular basis to ensure that appropriate investigation, corrective action, and/or escalation is conducted as required for recurring trends involving products, methodologies, instrumentation and scientists. This includes taking appropriate action to drive timely resolution of laboratory nonconformance’s and CAPA to meet applicable goals.
• Monitoring data from Contract Laboratories including non-conforming test results. Interfacing with contract laboratory during the laboratory investigation process.
• Leads, develops, trains and coach’s lab associates within the laboratory. This includes ensuring that associates have appropriate resources and support to execute testing in accordance with procedures, standards and regulations as well as ensuring that all relevant core competency training modules are completed by the laboratory personnel.
• Maintaining up to date knowledge of the company’s products and manufacturing processes related to relevant laboratory testing.
• Providing audit support (front room, back room and SME).
• Working with cross functional teams to successfully resolve audit findings, product non-conformances, customer complaints, to execute Corrective/Preventive Actions and/or to improve product design.
• Monitoring departmental activities to ensure that laboratory personnel follow all company guidelines related to Health, Safety and Environmental practices.
• Ensuring the timely completion of document reviews and approvals for document changes within their area of responsibility
• Participating in budget planning for the laboratory.
• Educate & train and qualify the new comer in laboratory and supervise the testing activity.
• Review Test method validation and test method life cycle management for chemical & Physical test methods.
• Managing stability testing including the escalation of stability alerts to management
  • Working closely with QE in support of development, troubleshooting, validation.
  • Act as Subject Matter Expert (SME), train and coach others.
  • Performing other related duties, as assigned by management as and when required.
• Act as Subject Matter Expert (SME), train and coach others.
• Performing other related duties, as assigned by management as and when required.
• Monitor audit trail for lab software.
• To conduct Test method validation and test method life cycle management for chemical & Physical test methods.
• Procurement and inventory management of chemicals, glassware and consumable required at laboratory.
• Handling of Instrument Life Cycle management and create and review document like URS / IQ/OQ/PQ protocol and report.
• Laboratory Calibration, preventative maintains and master validation plan.
• Protocol preparations for the design experiment.
• Working closely with cross functional team in support of development, troubleshooting, validation activities.
• Testing of Sterility test, Microbial limit test, environmental monitoring, Biracial Endotoxin, Water testing, Bio-burden testing and Growth promotion testing.
• Test method validation and test method life cycle management for microbiology test methods.
• Media preparation and inventory management.

• Education: Graduate or Postgraduate in Chemistry.
• Experience: Minimum 6 to 10 years of experience in Chemistry or Microbiology function and Analytical instruments handling. Preferably local F.D.A. (Food & Drugs Administration) as A.T.S. (Approved Technical Staff).

Technical Skills / Behavioral Skills

Functional competencies:

• Knowledge of GxP Documentation and of following areas like Test Method and Specification, Instrument operation procedure, current regulations. Departmental SOP’s, Report writing / Data analysis, OOS / NC procedures and Data Integrity issues.
• QMS: In depth knowledge of tools for investigation of OOS / NC, Audit trail reviews and capabilities of analyzing its impact assessment.
• Cross Functional coordination: Coordination skills with all stake holders.
• Instrumentation and Analysis: Overall knowledge of Instrumentation and analysis.
• Qualification and Certification: Process experience. Overall knowledge of Product / Business priorities / Projects. Authority of decision making base on facts. Overall expertise in elements of one section of Technical Competency, leading in Fundamental skills, Professional skills & Behavior skills. Must be expert for Supervision & process knowledge.

Professional Competencies

• Operational Excellence: Analytics & Problem Solving, Technology & Data Management, Decision Making, Knowledge Management.
• Quality & Compliance: Quality Mindset, Compliance Orientation, Environment Health & Safety
• Business Fundamentals: Financial Management & Budgeting, Project Management, Business Case Development, Business Orientation,
• Business Partnering: Influencing, Change Management, Time Management, Global Mindset & Management,