Johnson & Johnson looking for Commercial Quality Senior Executive - M.Pharm, B.Pharm, MSc Apply

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.

Post : Senior Executive, Commercial Quality - Mumbai

Job Description
Overall purpose of job : Responsible for the Quality Management System (QMS) establishment, maintenance & implementation at Johnson and Johnson Innovative Medicine (J&J IM) India and Pharm-dedicated 3PL Distribution Centers according to established Quality Manual to provide consistency in managing activities performed at multiple sites to meet customer expectations, applicable regulatory requirements, and Johnson & Johnson policies and standards

Key responsibilities
1. GxP Compliance at 3PL Distribution Centers:
• Follow adequate and appropriate quality management systems in collaboration with Deliver, where applicable, and followed at the 3PL Distribution Centers.
• Ensure compliance to requirements for temperature sensitive products (Cold-Chain and cool chain products)
• Support compliance related to J&J IM products handled by standalone/cross sector 3PL Distribution Centers in co-ordination with cross sector owning segment Commercial Quality (e.g., Product Returns, Field Actions, Market complaints, temperature excursions etc.)
• Support during HA inspections at Pharm DC’s and reporting in Curve.
• Provide support for investigations of the Quality Issues and monitor CAPA actions
• Provide trainings on J&J IM India SOPs to DCs on need basis
• Support Management of controlled substances
• Escalate issues observed during handling of controlled substances
• Responsible for providing quality oversights for facilities, utilities qualification and validation activities for CFAs and DCs
• Support for preparing validation master plan and executing the same
2. Change Management:
• Ensure that all changes related to J&J products and critical changes at External Manufacturing Sites, 3PL warehouses and within J&J IM India are managed through change control system. The changes are assessed for its impact, executed & closed in compliance the regulatory & corporate requirements
• Ensure appropriate internal and external change control systems are in place and are followed
• Support execution of Change Control Review Board

3. Local Procedure Management:
• Prepare and update applicable LOC procedures in accordance with local GMP/GDP, BQM and J&J requirements through Tru Vault Document Management system
• Ensure Tru Vault access is granted/ modified based on user’s need by admin access
4. Non-Conformance Management/CAPA Management
• Ensure that all non-conformances related to JNJ products, process or systems are suitably, scientifically and logically handled, documented, investigated for root cause, assessed for its impact on product quality and safety through appropriate system
• Ensure that appropriate Corrective actions & Preventive actions are taken to mitigate the effect of nonconformance and recurrence in future as per process
5. Batch Release of Imported products sold in India & Quarantine Release
• Ensure that the J&J IM SC Site products imported in India are released in ERP (SAP System) after satisfactory evaluation of the temperature data (for cold chain products), certificate of analysis, certificate of compliance and health authority test reports (wherever applicable)
• Escalate the issues pertaining to the product, temperature excursion to the J&J IM SC Site Quality in event of any product quality or shipment issue via Trackwise system
6. Complaint Management
• Receive, acknowledge, log, investigate, assess the incoming Product Quality Complaints (PQC) and AEPQCs timely (India and affiliate- Srilanka, Bangladesh and Nepal countries)
• Timely communication of complaints to the Manufacturing site and adverse events to the LSO for reconciliation, investigation and closure
• Managing the market complaints via EZ reporter, Smartform & PQMS
• Reconciliation of complaints weekly & monthly with PV
7. Training Management:
• Role based assessment of the SOPs, maintaining training curriculum as per identified roles and User Mapping for India LOC
• Addition and Deletion of employees in specific user groups/ roles. Creation and obsoletion of curriculums assignation of training through applicable training management system
• Ensure the appropriate training for all applicable stakeholder’s manual as well as through Training management system (Compliance wire and Summit)
• Ensure, all assigned training completions is done within the due date by the stakeholders involved

8. Repackaging/Relabeling
• Ensure correct processes are followed during Repackaging & Relabeling at Repacker’s site
• Approval of repackaging requests, Certificate of compliance and other related repackaging activities as per process.
• Maintenance of the Image Master
• Ensure approval of the label artworks of all the local and imported products is done to be compliant to regulatory requirements, license and other applicable rules
• Provide quality oversight on serialization activities carried out on J&J IM India Products
• Ensure Traceability and Verification of J&J IM India products on need basis.
9. Temperature Excursion Management
• Implement a documented process to control and monitor (where applicable) the temperature conditions during storage and distribution for all temperature sensitive products. Decision on usage or rejection of products in case of Temperature Excursion-India
10. Return Products handling
• Ensure evaluation of all returned goods before rejecting or re-issuing
11. Product Recall/ Mock Recall
• Support Product recall operation and related documentation.
12. Curve, React and Audit records Management
• Support the creation of the curve, react and audit records with appropriate documentation in line with the good documentation practice requirements
• Timely revision of the records and ensure closure abiding the associated timelines

13. Suppliers and Distributor Management
• Support Quality Visits/ audit to suppliers and distributors
• Prepare/ Review/ Share Visit/ Audit report and support for monitoring CAPA actions
• Lead Supplier Audit/ Distributor Visits and track the Audit actions/ CAPA implementations
• Trainings to Distributors for Handling Storage, Distribution and regulatory Compliance
• Management of Approved Supplier List and associated documents
14. Internal Audits Management
• Responsible for management of internal audit schedule, execution and documentation as per process.
15. CAPA Review Board/ Local Change Control Meetings
• Responsible for assessment of the data for subsequent CRB/ LCCB period
• Organize CAPA Review Board meetings/ LCCB (on need basis) and Document the comments/ improvement points suggested by CRB/ LCCB and circulate MOM
• Track the modification of QI/ CAPA/ COC as per comments received by CRB/ LCCB
16. Imported Product Testing from NABL Accredited Lab
• Responsible for coordinating with contracted lab for testing within predefined timelines
• Responsible for coordinating with supply chain for testing requirements and sample delivery
• Responsible for coordinating with regulatory for ordering and maintaining stock of reference standards, impurities etc.

17. Field Actions
• Support execution of field actions
• Coordinate with relevant stakeholders for field action execution and respective documentation
18. Data Management and Quality Record management
• Support Management of Quality Records as per the WWRIM schedule
• Support activities related to destruction of records which have passed the timeline mentioned in WWRIM policies
19. Controlled Substance Management
• Support Management of controlled substances
• Escalate issues observed during handling of controlled substances
20. Other Collaboration
• Collaborate effectively with various internal partners like LSO, EQ, Finance, Supply chain, Deliver, SQ, MSAT, PES, Sales & Marketing, Legal, Brand Protection, PV, HR and MAF and other regional functions supporting complaint management like CCVs, Training Management. Collaborate external partners such as the Local Health Authorities, as applicable

Candidate Profile
• Graduation or Post Graduation in Science - Preferably Pharmacy
• At least 5 years ideally (5-7) Year’s experience in the Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations, Distribution Warehouse management and Regulatory Affairs, Where the position requires oversight of manufacturing / packaging / testing operations activities (internal or external), Manufacturing / QA operations experience is essential
• Expert in Microsoft Office, Expert in investigations with knowledge on investigational tools, Proficient in Supplier audits, basic understanding of new technologies in pharma industry
• Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP
• Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes
• Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners
• Full competency in local languages and English

Additional Information
Experience : 5 years
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Commercial Quality
End Date : 5th June 2025