Manager, Process & Personnel Qualification Management Expert
About The Position
Johnson & Johnson is seeking a Manager, Process & Personnel Qualification Management Expert to join its Process & Data Management Team. The role drives compliance and quality excellence in the pharmaceutical industry by leading process improvement projects and using digital tools to support the transformation from traditional processes and training to a data-centric content and qualification management system. The position leads Pharmacovigilance (PV) process and training projects, including process development and mapping, and training development, qualification, and delivery. As a quality partner for Innovative Medicines Office of the Chief Medical Officer (IM OCMO), the role connects business partners, quality groups, and governance, helping the GxP Quality Framework adapt proactively to business and regulatory changes. The manager oversees project tasks, timelines, and deliverables; addresses issues and risks; and provides progress updates to management and business owners. The role also supports implementation of the digital transformation roadmap and may support or lead other projects, meetings, audits, and inspections as directed.
Requirements
- Bachelor’s degree in Science or Business.
- At least 5 years of experience in a medium- to large-scale matrix organization.
- At least 5 years focused on pharmaceutical or device compliance.
- Exceptional oral and written English communication skills, including the ability to explain complex ideas clearly and effectively.
- Understanding of global (pre)clinical safety and pharmacovigilance compliance regulations and guidelines, and experience with the life sciences industry's regulatory framework.
- Demonstrated expertise managing complex projects and fostering collaboration among diverse teams and departments.
- Strong attention to detail and analytical thinking to evaluate business processes and implement improvements.
- A track record of personal leadership, relationship-building, working autonomously, and cultivating an inclusive work atmosphere that values diversity.
Nice To Haves
- Master’s degree.
- Experience in process design and training design.
- Skills in Business Process Management (BPM), Business Requirements Analysis, Coaching, Compliance Management, Cross-Functional Collaboration, Data Savvy, Fact-Based Decision Making, ISO 9001, Leverages Information, Process Governance, Process Improvements, Process Optimization, Quality Control (QC), Quality Standards, Quality Validation, Stakeholder Engagement, Standard Operating Procedure (SOP), Tactical Thinking, and Technical Credibility.
Responsibilities
- Lead Pharmacovigilance (PV) process and training-related projects, including process development, mapping, training development, qualification, and delivery.
- Serve as a quality partner for Innovative Medicines Office of the Chief Medical Officer (IM OCMO), connecting business partners, quality groups, and governance.
- Help ensure the GxP Quality Framework adapts proactively to business and regulatory changes.
- Manage project tasks, timelines, and deliverables; address issues and risks; and provide timely progress updates to management and business owners.
- Support implementation of the digital transformation roadmap toward data-centric content and a robust qualification management system.
- Support or lead additional projects, meetings, audits, and inspections as directed.
Benefits
- Participation in the Company’s consolidated retirement plan (pension), subject to plan terms.
- Participation in the Company’s savings plan (401(k)), subject to plan terms.
- Vacation: 120 hours per calendar year.
- Sick time: 40 hours per calendar year, with specified higher amounts for employees residing in Colorado or Washington.
- 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 the birth, adoption, or foster care of a child.
- Bereavement Leave: 240 hours for an immediate family member and 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
