Lead, Complaints - Raritan, United States - Johnson & Johnson

Johnson & Johnson

Verified Company

Raritan, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Johnson & Johnson is recruiting for a Lead, Complaints / Adverse Events in Raritan, NJ or near a Johnson & Johnson office in India, Switzerland, Belgium, or the United States.

This position will require up to 20% travel.

Per our J&J Flex Policy, the expectation for this position is to work in the nearest Johnson and Johnson office 34 days per week and work from home 12 days per week. _

Enterprise Quality is a comprehensive organization within J&J that focuses on ensuring the highest standards of quality & compliance.

It encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services, including specialized support for Transportation Operations and Temperature Control.

Additionally, it includes a Transformation Office dedicated to steering strategic imperatives and enhancing the Quality & Compliance organization's strategy through initiatives like Data Strategy, Automated Product Release, and Digitalization of Quality Management Systems.

The group further comprises a Data & Digital Strategy function tasked with developing and executing a holistic digital and data strategy to improve quality and compliance, covering areas such as Data Foundations, AI/ML & IoT technologies, Quality & Compliance Innovation, and Digital Assets validation.

To facilitate the deployment of these strategic initiatives, the group employs two Deployment Offices for the MedTech and MedTech segments and maintains a global presence through three regional leaders managing operations in Asia Pacific (ASPAC), Europe, Middle East, Africa (EMEA), and the Americas.

Within Enterprise Quality (EQ), the IM Deployment office drives targeted strategic transformation and quality operations (CSV) initiatives aligned with the Innovative Medicine (IM) segment strategic priorities.

The Lead, Complaints / Adverse Events is responsible for guiding and managing the team throughout the building and execution of quality into enterprise wide systems, tools, services and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, retire).

The Lead, Complaints / Adverse Events will:

Ensure that all J&J quality standards and global regulatory requirements are met
Own the quality approach for systems and hold teams accountable for delivering an endtoend support model
Provide technical and procedural expertise/guidance to project teams, aligning with internal and external stakeholders
Support internal audits and Health Authority regulatory inspections
Approve SDLC validation documentation deliverables, including release of system implementations/changes for production
Attend project team meetings, offering EQ quality and compliance guidance and support
Collaborate with globally diverse teams in an inclusive environment
Promote an environment fostering the company's credo and the value of a diverse workforce
Serve as a trusted partner across the Enterprise Quality organization, fostering strong collaboration skills at the project team level, internally and externally
Develop and maintain an effective working partnership with senior management
Collaborate with other leaders and staff within IM Deployment Office and Quality Operations group to ensure each function is executed in an efficient manner
Ensure timely reports of status and metrics as required by the IM Deployment Office organization
Ensure timely completion of assigned training and expense reports

Qualifications:

Requirements:

A bachelor's degree in computer science, Information Systems, Business Administration or another related field required. Solid, relevant experience may be substituted when appropriate, additional certifications a plus
6+ years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities
Experience authoring or approving validation protocols, nonconformities, Change Requests, SOPs, Validation Plans and Reports
Project Management experience
Ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands
Superior written and oral communication skills
Ability to perform work with a high degree of independence in terms of selfmanagement of a large variety of tasks and initiatives regarding quality and validation
Ability to manage multiple and competing projects
Knowledge of SDLC Quality Management process and Computerized System Validation/Computerized System Assurance principles
Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820
Experience working effectively in a highly matrixed team environment
Project management and organizational skills

Preferred: