Manager, Quality Control

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.  Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.  Learn more at https: //www. jnj. comJob FunctionQualityJob Sub FunctionQuality ControlJob CategoryPeople LeaderAll Job Posting Locations: Aurangabad, Maharashtra, IndiaJob DescriptionSECTION 1:

JOB SUMMARY* Under the direction of the Director Quality Operations/Site Quality Head, with the objective ofmaintaining high quality standards for the product manufacturing process and compliance withregulatory requirements, administers Quality Control support to the New Products Introduction,Supply Chain, and directly supervises Quality Control associates and non-exempts in day-to-dayactivities supporting manufacturing lines, all in accordance with applicable regulations andEthicon written specifications and quality standards. Defines India and/or functional strategies and contributes to global strategies for a Quality lab. Creates and manages multiple complex testing techniques/instruments that result in theaccomplishment of multiple business objectives.

Leads the analysis of highly complex issues andestablishes resolutions and or decision points for programs and/or projects. Identifies novelscenarios and nascent scientific/technical opportunities and seeks to contribute to theimprovement of processes that enable scientists to cultivate new scientific insights. Manager QC is responsible for the overall management of the quality laboratory. responsible for driving continuous Quality Excellence, maintaining supply chain compliance, providing franchise support, and communicating internal and external customer facing needs to Site Quality Leaders. This includes support in the delivery of critical initiatives for Medical Device and Supply Chain Quality.

In addition, they will identify and facilitate the implementation of key capabilities at the site that will give the Quality team a competitive advantage. Plans, coordinates, and direct Quality control activities to ensure continuous production ofproducts consistent with established quality & regulatory standards by performing the assignedduties and responsibilities to support manufacturing and timely delivery of product to customers. SECTION 2: DUTIES & RESPONSIBILITIES*In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Provides Management and Leadership in a laboratory environment.

Manages laboratory resources to ensure the appropriate level of support and prioritization formanufacturing activities and timely delivery of products to customers. Ensures all laboratory activities are conducted in accordance with government regulations, safetyRequirements, Enterprise, Sector And Company Policies. Ensures the appropriate oversight and guidance for laboratory investigations including reviewinginvestigations to ensure that reports are consistent, complete and in alignment with applicablestandards and procedures with appropriate content and references. Ensures cGMP compliance in all aspects of the laboratory functions. Ensures that all laboratory personnel have the required education and training to performassigned job responsibilities.

Ensures all relevant core competency training modules are deployed to the laboratory personneland that all laboratory procedures are aligned with the MD&D and Enterprise LaboratoryStandards. Ensures that laboratory equipment and systems are maintained in accordance with proceduresand standards. Ensures that validated/verified test methods and qualified and calibrated instruments are usedfor quality testing activities. provides oversight of Laboratory Instrument Lifecycle and Laboratory Software Lifecycle systems. Provides oversight of all Laboratory Quality Systems including Laboratory Change Management activities. Provides oversight of Quality Agreements with Contract Laboratories to ensure excellent and appropriate communication between laboratories.

Additionally, working with procurement to develop business agreements with Contract Laboratories. Ensures Reviewing and approving technical protocols and reports to support validation/verification and qualification activities. Ensures monitoring of laboratory metric trends on a regular basis and ensuring that appropriate investigation, corrective actions and/or escalation is conducted as required for recurring trends involving products, methodologies, instrumentation and scientists. Provides audit support. Leads /sponsors the implementation of improvement initiatives to address recurring laboratoryissues. Reviews and approves Quality Records (e. g. non-conformances, CAPA) related to laboratoryevents. Maintaining knowledge of the regulatory trends related to relevant laboratory testing.

Communicating and elevating critical business related issues as well as opportunities to seniormanagement. Planning, promoting and organizing required training activities related to different laboratorytesting areas. Establishing and maintaining an annual operational budget. Monitoring departmental activities to ensure that laboratory personnel follow all companyguidelines related to Health, Safety and Environmental practices. Promoting Good Saves safetyculture.

For those who supervise or manage a staff, responsible for ensuring that subordinates follow allCompany guidelines related to Health, Safety and Environmental practices and that all resourcesneeded to do so are available and in good condition, if applicableResponsible for ensuring personal and Company compliance with all Federal, State, local andCompany regulations, policies, and proceduresPerforms other duties assigned as needed. ❖ Compliance & Training Observes & promotes all regulatory requirements as defined per applicable regulations, rules& procedures established by the Company, and notified any violation or deviation to theimmediate supervisor or appropriate authority.

Complies with all training requirements to perform duties of the job. Ensure adherence/compliance to Records Management policies and procedures, asapplicable. ❖ Accountability Maintains 5S states of laboratory, GLP & GMP in laboratory. Over all Laboratory accountability. Team building and credo. Laboratory metric & its review. Laboratory work as per current procedure and test method. Audit readiness within laboratory. 2.

1 Authorities Chemical test / Microbiological test Raw Data/Report review and approve (Asapplicable) Laboratory Log book Review Rejection note approval Lab Investigation Report, Lab incident approve (As applicable) PR/PO approval Internal and Cross functional document approval through applicable PLM/ADAPTIVsystem EtQ (NC , CAPA, audit observation, change request) approval OPEX/CAPEX finance related approvals Review / Approve Instrument Qualification/calibration/PM/AMC / validations /servicereports/TMV documentation. Approve Outward/Inward Gate pass (as applicable)SECTION 3: EXPERIENCE AND EDUCATION* Graduate/Postgraduate/Ph.

D in Science degree, preferably in a relevant scientific/technical field/Pharmaceutical Sciences and 12 or more years of relevant experience in QMS environment. (OR A minimum of 12 years responsibility and experience in a highly regulated environment isrequired including a broad and deep working knowledge of the operating functions of quality andcompliance, supply chain, material supply and material handling and control, productmanufacturing and product packaging. Minimum 5 years of experience in Supervisory orManagerial cadre. An understanding and application of cGMP and internal/external HealthAuthority compliance expectations is required.

Excellent communication, collaboration, and influencing skills across multiple functions and levelswithin the organization is required. Prior experience with regulatory inspections is desirable. Prior experience with project management, Lean, Six Sigma, Operational Excellence, change management training and/or certification is desirable. SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES andAFFILIATIONS*Technical Skills / Behavioral SkillsFunctional Competencies Understanding of theory, and practical applications, of experimental techniques within a Qualitylab, as well as key processes and activities, and the interdependencies and interactions with otherfunctions. Conducting audits of in-house Quality labs and contract/external Quality labs.

Technical understanding of, and ability to interpret, applicable regulatory agency regulations andindustry standards. Implementing innovative approaches to solving technical problems and troubleshooting, withlimited guidance from management or other scientific personnel, while maintaining a high level ofcGMP awareness. Professional Competencies Operational Excellence: Analytics & Problem Solving, Technology & Data Management, DecisionMaking, Knowledge Management. Quality & Compliance: Quality Mindset, Compliance Orientation, Environment Health & Safety Business Fundamentals: Financial Management & Budgeting, Project Management, BusinessCase Development, Business Orientation, Business Partnering: Influencing, Change Management, Time Management, Global Mindset &Management.