Manager, Infrastructure - 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 Manager, Infrastructure in Raritan, NJ or near a Johnson & Johnson office in India, Switzerland, Belgium, or the United States.

This position may require up to 20% travel (domestic and internationally).

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.

Quality Operations (QO) manages validation/qualification of infrastructure and data platforms in accordance with J&J's Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with closing compliance gaps related to audits and inspections.

Additionally, Quality Operations oversees the Quality Management Systems for Technology Services and Enterprise Functions and administers the Commercial Quality Shared Services functions of temperature control and transportation quality operations.

The Manager, Infrastructure 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 Manager, Infrastructure 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
Develop and maintain an effective working partnership with senior management
Collaborate with other leaders and staff within Quality Operations group to ensure each function is executed in an efficient manner
Ensure timely reports of status, metrics and time sheets as required by the Quality Operations organization
Ensure timely completion of assigned training and expense reports
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 Quality Operations group to ensure each function is executed in an efficient manner
Ensure timely reports of status, metrics and time sheets as required by the Quality Operations organization
Ensure timely completion of assigned training and expense reports

Qualifications:

Requirements:

A Bachelor's degree in Computer Science, Information Systems, Business Administration or other related field required
A minimum of 8 years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required
A minimum of 3 years of experience with direct experience in stakeholder management
Experience authoring or approving validation protocols, nonconformities, Change Requests, SOPs, Validation Plans and Reports is required
Experience managing and leading global technology programs along with FTEs/consultant teams across multiple geograp