Manager, Process & Personnel Qualification Management Expert

Johnson & Johnson•Titusville, PA

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-related projects, including process development and mapping, and training development, qualification, and delivery. It partners with Innovative Medicines Office of the Chief Medical Officer (IM OCMO), connects business partners with quality groups and governance, and helps ensure the GxP Quality Framework adapts proactively to business and regulatory changes. The role manages project tasks, timelines, and deliverables; addresses issues and risks; and provides progress updates to management and business owners. It also supports implementation of the digital transformation roadmap and may support or lead additional projects, meetings, audits, and inspections as directed. The position is available at U.S. locations in Horsham, Pennsylvania; Raritan, New Jersey; and Titusville, New Jersey. The stated pay range is $105,000 to $181,700 for U.S. hires. Johnson & Johnson describes itself as an equal opportunity employer and offers an inclusive interview process, including accommodations upon request.

Requirements

Bachelor’s degree in Science or Business is required.
At least 5 years of experience in a medium- to large-scale matrix organization.
At least 5 years of experience focused on pharmaceutical/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.
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.
Experience in training design.
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.
Technical Credibility.

Responsibilities

Lead Pharmacovigilance process- and training-related projects, including process development and mapping, and training development, qualification, and delivery.
Serve as a quality partner for Innovative Medicines Office of the Chief Medical Officer, fostering collaboration and linking 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 to support successful project outcomes.
Address project issues and manage risks.
Provide timely project 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

Company consolidated retirement plan (pension), subject to plan terms.
401(k) savings plan, subject to plan terms.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with different stated allowances 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.