Manager, Quality Control

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SECTION 1: JOB SUMMARY*
Under the direction of the Director Quality Operations/Site Quality Head, with the objective of maintaining high quality standards for the product manufacturing process and compliance with regulatory requirements, administers Quality Control support to the New Products Introduction, Supply Chain, and directly supervises Quality Control associates and non-exempts in day-to-day activities supporting manufacturing lines, all in accordance with applicable regulations and Ethicon 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 the accomplishment of multiple business objectives. Leads the analysis of highly complex issues and establishes resolutions and or decision points for programs and/or projects. Identifies novel scenarios and nascent scientific/technical opportunities and seeks to contribute to the improvement 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 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.

SECTION 2: DUTIES & RESPONSIBILITIES* In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: o Provides Management and Leadership in a laboratory environment. o Manages laboratory resources to ensure the appropriate level of support and prioritization for manufacturing activities and timely delivery of products to customers. o Ensures all laboratory activities are conducted in accordance with government regulations, safety requirements, Enterprise, Sector and Company policies. o Ensures the appropriate oversight and guidance for laboratory investigations including reviewing investigations to ensure that reports are consistent, complete and in alignment with applicable standards and procedures with appropriate content and references. o Ensures cGMP compliance in all aspects of the laboratory functions. o Ensures that all laboratory personnel have the required education and training to perform assigned job responsibilities. o Ensures all relevant core competency training modules are deployed to the laboratory personnel and that all laboratory procedures are aligned with the MD&D and Enterprise Laboratory Standards. o Ensures that laboratory equipment and systems are maintained in accordance with procedures and standards. o Ensures that validated/verified test methods and qualified and calibrated instruments are used for quality testing activities. o provides oversight of Laboratory Instrument Lifecycle and Laboratory Software Lifecycle systems. o Provides oversight of all Laboratory Quality Systems including Laboratory Change Management activities. o 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. o Ensures Reviewing and approving technical protocols and reports to support validation/verification and qualification activities. o 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. o Provides audit support. o Leads /sponsors the implementation of improvement initiatives to address recurring laboratory issues. o Reviews and approves Quality Records (e.g. non-conformances, CAPA) related to laboratory events. o Maintaining knowledge of the regulatory trends related to relevant laboratory testing. o Communicating and elevating critical business related issues as well as opportunities to senior management. o Planning, promoting and organizing required training activities related to different laboratory testing areas. o Establishing and maintaining an annual operational budget. o Monitoring departmental activities to ensure that laboratory personnel follow all company guidelines related to Health, Safety and Environmental practices. Promoting Good Saves safety culture. 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 o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures o Performs 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 the immediate supervisor or appropriate authority. Complies with all training requirements to perform duties of the job. Ensure adherence/compliance to Records Management policies and procedures, as applicable. 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 (As applicable) 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/ADAPTIV system EtQ (NC , CAPA, audit observation, change request) approval OPEX/CAPEX finance related approvals Review / Approve Instrument Qualification / calibration / PM / AMC / validations /service reports/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 is required including a broad and deep working knowledge of the operating functions of quality and compliance, supply chain, material supply and material handling and control, product manufacturing and product packaging. Minimum 5 years of experience in Supervisory or Managerial cadre.An understanding and application of cGMP and internal/external Health Authority compliance expectations is required. Excellent communication, collaboration, and influencing skills across multiple functions and levels within 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 and
AFFILIATIONS* Technical Skills / Behavioral Skills Functional competencies: Understanding of theory, and practical applications, of experimental techniques within a Quality lab, as well as key processes and activities, and the interdependencies and interactions with other functions. Conducting audits of in-house Quality labs and contract/external Quality labs. Technical understanding of, and ability to interpret, applicable regulatory agency regulations and industry standards. Implementing innovative approaches to solving technical problems and troubleshooting, with limited guidance from management or other scientific personnel, while maintaining a high level of cGMP awareness. 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.