Lentiviral Vector (LV) Investigations Manager

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Supply Chain Manufacturing

Job Sub Function:
Manufacturing Pharmaceutical Process Operations

Job Category:
People Leader

All Job Posting Locations:
Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Lentiviral Vector (LV) Investigations Manager to join our team in Raritan, NJ.

Summary:

LV Investigations Manager leads all aspects of a team of individual contributors and/or supervisors in support of activities related to investigations, CAPAs and Quality Systems.

Ensuring GMP compliance, accuracy and key quality deliverables are completed in accordance with required timelines.

Carries out duties in compliance with all local, state and federal regulations and guidelines (including FDA, EPA, and OSHA) as well as all company and site policies and procedures.

Key Responsibilities:


* Develops strategy for routine investigations data collection, analysis, track & trend deviations, manage quality system metrics for deviations and report at site and cross-site levels.


* Provide technical and managerial leadership to drive efficient, compliant, and effective Lentivirus investigations team.


* Supports and owns metric related actions and activities.

Responsible for driving site metrics and quality topics and proactively identifying issues for management for review.


* Review/approve documents as an investigations department subject matter expert (SME).

Support investigation of nonconformances, CAPAs and change controls.


* Provides guidance on key controlled documents for QMS activities, escalations, and significant issues.


* Ensures all non-conformances are thoroughly investigated with root cause identified and appropriate CAPA’s implemented.

Drives continuous improvement in Root Cause Investigation Process.


* Advises business partners on compliance with all company and site policies standards and procedures.


* Collaborates with business partners to resolve complex issues
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