Local Quality & Compliance Manager
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science — bringing creative ideas, products and services to advance the health and well-being of people. Every single day, our more than 130,000 employees across the world are blending heart, science and creativity to deeply change the trajectory of health for humanity.Janssen Research & Development area develops treatments that improve the health and lifestyles of people worldwide. R&D development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. The Principal Scientist Technical Integrator is the DPD (Drug Product Development) representative and single point of contact on the CMC new product development teams.
Janssen India, the pharmaceutical division of Johnson & Johnson India is recruiting for Local Quality and Compliance Manager located in Mumbai
- The Local Q&C Manager is responsible for performing activities within the assigned country/countries that
- ensure an integrated and comprehensive quality compliance approach for clinical trials in close collaboration with local and global quality functions, and
- ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson / Janssen global processes and procedures.
- Keep close track and oversight on recurrent issues in stability lab and ensure necessary adequate actions are defined to prevent further occurrences
- Responsible for being spokesperson during an internal and external inspection
- Responsible for overall quality and compliance with regards to handling controlled substances and ensuring that local /global regulations are adhered to
- The Local Q&C Manager has a dual reporting line into the Local GCO Head and Regional Q&C Leader and is a member of the regional Q&C management team. He/she may oversee and direct one or more Q&C Specialists.
- PG in Science or Pharmacy
- Has to have experience in conducting Clinical trials audits in the past 2-3 years
Experience and Skills:
- 8-10 years’ experience with 2-3 years exp in clinical trial audits
- Experience of facing regulatory audits
- Ability to communicate
- Decision-making skills and Quality Acumen
- Big picture thinking / able to work with process flows
Are you ready to impact the world?
Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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