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 day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
Bioresearch Quality Control (BRQC) is recruiting for a Manager, ICSR Quality, located in either Mumbai, India or Manila, Philippines.
This role is within the Bioresearch Quality and Compliance (BRQC) organization under Compliance Strategy and Analytics (CSA). The Manager, ICSR Quality should have significant experience with Individual Case Safety Report quality processes and oversight, as well as sound knowledge of the end to end Pharmacovigilance (PV) process including the CAPA process and structure of a PV Quality System.
• Manages the PV Quality Review processes supporting Office of Consumer Medical Safety (OCMS) and the Global Medical Organization (GMO) including but not limited to:
- End-of-Line Quality Review of ICSRs for Consumer and Pharma sectors
- Oversees the conduct of PV quality review process and to ensure work efficiency and compliance to prevailing PV regulations.
- Leads regular quality operations meetings to discuss metrics, error trends, and issues escalation pertaining to ICSR quality
- Coordinates management of quality metrics and issues as appropriate
- Helps develop strategies to continually improve overall ICSR quality
• Coordinates with Compliance Senior Management and QPPV to ensure consistent fulfillment of the global PV obligations
• Partners with the operations teams and global case processing centers to develop strategies for cross-sector improvement of ICSR quality.
• Manages extended oversight of vendor quality performance for non-medicinal and medicinal consumer products as well as pharmaceutical products, working with multiple vendors.
• Responsible for opening a Quality Investigation for below threshold quality scores
• Has accountability for direct reports local and globally.
• Is ICSR quality leader for internal audits and external health authority inspections.
• Maintains compliance with company guidelines and HR policies
• Participates as SME on local or global project teams
Requirement: Bachelor's Degree Holder, MA/MBA preferred with 8 to 10 years experience in PV processes/product safety, ICSR quality, and/or regulatory affairs, with at least 7 years experience in a Pharmaceutical company.
Experience and Skills:
• Exhibits proven ability to project plan multiple simultaneous projects and initiative to produce results
• Instrumental in using advanced data analytics to capture metrics
• Process Excellence skills and experience
• Strong leadership, communication and presentation skills
• Diligence in record keeping and records organization.
• Proficient in Microsoft Applications (Outlook, Power Point, Intermediate to Advanced Excel, Word, Project)
• Experience with SharePoint, TrackWise
• Results oriented; able to independently create and deliver
• Displays strong collaboration and interpersonal skills when working on teams
• Has change management skills
Johnson & Johnson International (Singapore) Pte. Ltd. - ROHQ