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Manager, Process & Personnel Qualification
Johnson & Johnson. Lead Pharmacovigilance (PV) process and training-related projects .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading Pharmacovigilance processes and training projects while ensuring compliance with global regulations. Proven ability to manage complex projects, foster collaboration, and adapt quality frameworks to meet business needs.
Highest-signal resume keywords
Pharmacovigilance Process LeadershipProject ManagementRegulatory ComplianceTraining DevelopmentAnalytical Thinking
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Process DesignTraining DesignProject ManagementRegulatory ComplianceGxP Quality FrameworkData-Centric Content DevelopmentQualification Management SystemLife Sciences Regulatory FrameworkPharmaceutical ComplianceClinical Safety Regulations
Soft Skills
Oral CommunicationWritten CommunicationAttention to DetailRelationship BuildingCollaboration
Industry Keywords
Pharmaceutical IndustryLife SciencesInnovative MedicinesQuality AssuranceDigital Transformation
About the role
Key responsibilities & impact- Lead Pharmacovigilance (PV) process and training-related projects
- Develop, map, and improve processes
- Develop, deliver, and qualify training
- Serve as a quality partner for Innovative Medicines Office of the Chief Medical Officer
- Link business partners, quality groups, and governance
- Ensure the GxP Quality Framework adapts to business and regulatory changes
- Manage tasks, timelines, deliverables, issues, and risks
- Provide timely project updates to management and business owners
- Support implementation of the digital transformation roadmap
- Drive evolution toward data-centric content and a qualification management system
- Support or lead additional projects, meetings, audits, and inspections as directed
Requirements
What you’ll need- At a minimum a Bachelor’s degree in Science or Business is required
- A minimum of 5 years in a medium to large-scale matrix organization
- At least 5 years focused on pharmaceutical/device compliance
- Preferred experience includes process design and training design
- Exceptional proficiency in both oral and written English communication
- Understanding of global (pre)clinical safety and pharmacovigilance compliance regulations and guidelines
- Experience in the life sciences industry’s regulatory framework
- Demonstrated expertise in managing intricate projects and fostering collaboration among diverse teams and departments
- Keen attention to detail and robust analytical thinking abilities
- Established track record in personal leadership, building relationships, working autonomously, and cultivating an inclusive work atmosphere
Benefits
Comp & perks- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time – up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year