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Regional Quality Systems Lead

Mumbai, MH
Job Code:
  • Retail & Wholesale
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Job Details

Regional Quality Systems Lead for J&J Consumer Asia-Pacific will be responsible for the end-to-end (E2E) oversight and effectiveness of the Consumer Quality System for the region. Regional QS Lead has responsibility for working with all sites, Local Operating Companies and functions within the region for the following quality systems processes Quality Systems Management Review, Metrics, Change Control/Regional Document governance, Training, CAPA/NC/Inv, Escalation, Complaints Management, Internal Audit, Regulatory Inspection preparedness and management, Standards Management. As part of the Global Quality System function within J&J Family of Consumer Companies, the Regional Quality Systems Lead will additionally act as the Global Process owner for one or more of the quality systems processes owned by the QS function. Regional QS Lead is the key liason between Global Quality Systems and the regions and is accountable for communicating and leading new initiatives from Global Quality Systems and the Enterprise. This role is accountable for ensuring all Enterprise policies, standards and procedures are effectively communicated and deployed into the region and providing periodic updates back into Global QS and the Enterprise, including where roadblocks and gaps exist. Regional QS Lead responsibilities include, facilitation of the Quality Council meetings, Consumer Global Quality System Community of Practice, facilitate Regional Change Control Review board, facilitate Regional CAPA review Board, preparation and facilitate Regional Quality Systems Management Review, ensuring accuracy and oversight of Regional Quality Metrics and dashboards, governance of regional documents (QSPs).Qualifications KNOWLEDGE/SKILLS/ABILITIES/BEHAVIORAL REQUIREMENTSGraduate or Post-graduate degree in Science, preferably in Chemistry or Pharmacy. Additionally, a Management degree/diploma will be preferred. Around 8 10 years experience in the field of Quality Systems and Compliance within the regulated pharmaceutical / Medical Device industry. Comprehensive knowledge of applicable US and international regulatory requirements for design, development, manufacture, and post market surveillance and field actions. Regulatory inspection experience is highly desirable. Proven track record of development and implementation of efficient and effective quality system processes is beneficial. Track record of successful cross functional partnership. Experience in managing virtual teams in a highly matrixed environment. Superior written and verbal communication skills with English language proficiency.
Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 3-8


Quality Assurance | Quality Inspection | Total Quality Management
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