Janssen India, the pharmaceutical division of Johnson & Johnson India, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neuroscience and analgesia, dermatology, infectious diseases and metabolic diseases. Driven by a strong dedication to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world.
Post : AP Commercial Quality Project Manager
Job Description
The position will connect as required with the different stakeholders (Pharmacovigilance, Regulatory Affairs, Medical Affairs, Deliver, Supply, Government Affairs) within the global, regional team and at LOC level to agree process steps and strategic decisions on execution. Role will be responsible for creating and implementing the necessary ways of working (work instructions, process flows) to ensure a compliant launch of the vaccine and ongoing support during Emergency use of the product within the region. The incumbent will give first response support to the day to day challenges on the vaccine launch project and will escalate when strategic decision is needed for alignment.
Key Responsibilities
• Consolidate Regional responses for queries and requests from global, regional and LOC teams and stakeholders.
• Draft and align processes and ways of working for the launch of the COVID 19 vaccine in the APAC Region.
• Support Ongoing tasks and processes related to COVID vaccine launch for the APAC region regarding tactical alignment, tasks follow up and deliverables.
• Collaborate with stakeholders of the project to ensure proper understanding of key constraints and compliance requirements.
• Ensure any unexpected situation is properly handled, informed and escalated to avoid compliance impacts or project delays.
• Ensure deliverables required from Commercial Quality area for the region are completed on time
• Host and coordinate multi-function/Markets/regions meetings (if applicable)
• Provide mechanism for appropriate project tracking, monitoring, and reporting.
Candidate Profile
• Bachelor/Master in Pharmacy / Chemistry / Biosciences / Engineering / Operations Management (Business) or related subject
• At least 5 years’ experience in Quality & Compliance functions in highly regulated products industries (Pharmaceutical, Medical Devices or Cosmetics);
• Highly experienced in Project Management. Knowledge in Project Management tools is required.
• Robust expertise on Quality Systems and Processes within a Pharmaceutical industry (preferred) environment (creation, implementation, alignment).
• Fluent in English
• Proficiency in Microsoft Office tools (Excel, Power Point, Word) and digital system.
• Good skills in working under matrix structure (cross-function, cross-segment)
• Ability to work well with senior management personnel in an effective manner to communicate Quality and Compliance to them.
• Ability to make decisions about scheduling, allocation of resources, and leading priorities.
• Flexibility in time management (morning/evening calls)
• Working Knowledge of Quality and Regulatory requirements on APC region (preferred)
Core competencies required for this role
• Strong communication skills both written and verbal; Able to prepare clear presentation and messages.
• Critical and analytical thinking ability; has high information capacity with rapid pattern recognition and reflection
• Strong problem solving and decision-making skills, can create uncommon connections
• High social intelligence; strong ability to connect, relate, and influence.
• Driven; with initiative, goal oriented, resourceful, adaptable and persistence
• Shows self-confidence to break boundaries and can thrive in uncertainty
• Shows ample control, financially oriented.
Additional Information
Experience : 5 years
Qualification : Bachelor/Master in Pharmacy / Chemistry
Location : Maharashtra - Greater Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality
End Date : 20th June, 2021
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