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17/03 Dipti Sawant
HR at Johnson & Johnson

Views:272 Applications:49 Rec. Actions:Recruiter Actions:0

Johnson & Johnson - Manager - Local Quality & Compliance (8-10 yrs)

Mumbai Job Code: 809301

Job Description : Janssen India, the pharmaceutical division of Johnson & Johnson India is recruiting for Local Quality and Compliance Manager, Global Clinical Operations (GCO) located in Mumbai.

Key Responsibilities :

- The Local Q&C Manager, GCO is responsible for performing activities within the India that ensure an integrated and comprehensive quality compliance approach for clinical trials being conducted in India 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 Janssen global processes and procedures.

- Monitor compliance risk and ensure mitigation/remediation actions are defined

- Monitor progress and confirm effectiveness of remediation plans, perform special investigations and plan, prepare, conduct and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner. More specifically perform the following risk based activities:

- Conduct On-Site Quality Monitoring Visits (OSQMVs)

- Perform assigned reviews of Trial Master File, training compliance documentation and other checks per QP&S

- Integrated Quality Plan for the trial

- Planning and execution of local QC checks

- Support and advise local and central study teams in root cause analysis of significant observations

- Ensure appropriate filing of the QC reports

- Conduct Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals

- Collaborate with local and central business partners to facilitate (local) inspections and office audits as needed

- Collaborate with local and central business partners in timely CAPA setting and implementation.

- Develop and manage local procedural documents

- Support onboarding of new hires

- Manage learning events / local workshops to support QMS and compliance awareness, Lessons Learned, etc

- Provide advice regarding SOP, system and GCP questions. SME in most areas.

- Go to person for managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk.

- The Local Q&C Manager has a dual reporting line into the Local GCO Head and APAC Regional Q&C Leader, and is a member of the regional Q&C management team.

- Responsible for being spokesperson during internal and external inspection

- The role is currently that of Individual Contributor but in the future there is a possibility that He/she may oversee and direct one or more Q&C Specialists.

Qualifications :

Education : PG in Life Science or Pharmacy

- A minimum of 8-10 years of previous Pharmaceutical Industry experience is required, with at least 3-4 years of GxP experience within clinical research and development and/or quality assurance.

Experience and Skills :

- Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions in the last 2-3 years is a mandatory requirement

- Should have last 2-3 years- experience in quality and compliance roles within the clinical operations department of a Multinational Company

- Expertise in working with various computer systems (Medidata, EDC systems, CTMS, SharePoint etc.)

- Experience of facing regulatory Inspections, internal audits

- Knowledge of the overall drug development process

- Well-developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)

- Ability to translate data into information and strategies into executable action plans improving the business

- Ability to motivate professional colleagues and stakeholders

- Conflict resolution/management and negotiation skills

- Ability to independently plan, organize, coordinate, manage and execute assigned tasks

- Ability to communicate both internally and with external stakeholders

- 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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Women-friendly workplace:

Maternity and Paternity Benefits

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