Be an early applicantLess than 25 applicants

Company

Original Job Post

Johnson & Johnson · 2 days ago

Manager, Product Life Cycle TQ&C

Raritan, NJ

Full-time

Onsite

Senior Level

$95K/yr - $155K/yr

6+ years exp

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Health CareMedical Device

H1B Sponsorship

Comp. & Benefits

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Responsibilities

Ensuring that all J&J quality standards and global regulatory requirements are being met.

Build and execute activities including early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation.

Lead the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope.

Provide technical and procedural expertise/guidance to project teams and align with internal and external partners.

Support internal audits and Health Authority regulatory inspections.

Approve SDLC validation documentation and system implementation/release for production use.

Lead globally diverse teams, nurture future leaders, and create growth opportunities.

Manage and mentor talent for career development.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Healthcare technologyValidation programsQuality management systemsData integrityCybersecurityRegulatory complianceProject managementAgile methodologyDevopsPmoSdlcGamp 5ItilComputer system validationMedical device regulationsProblem-solvingLeadershipCommunicationMentoringCollaborationInterpersonalInfluence

Required

A minimum of a Bachelor’s degree in Computer Science, Engineering, Information Systems, Business Administration or other related field required; advanced degree preferred; additional certifications a plus

A minimum of 6 years of progressive experience in the pharmaceutical, medical device, biotech industry, with direct experience in Healthcare Technology activities

Experience in running large scale end-to-end Validation programs like PLM, Regulatory, LMS, and Change Control is required

Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports is required

Proficiency in skills including, Quality Strategy, Applications and Infrastructure, Data Integrity, Quality Theory, Testing, Quality Management Systems

Familiarity and awareness of cybersecurity and privacy principles and implications for quality and risk management

Advanced understanding of Global and Regional GxP Regulations

Solid understanding of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable

Knowledge of GxP regulations, including computer system validation, data integrity and medical device regulations

Solid grasp of Agile Development Methodology and DevOps

Sets vision and ensures adoption for how quality will be designed into and maintained within a technology solution

Identifies critical skills and capabilities required to ensure the development of a highly skilled, high performance team

Responsible for the development of direct/indirect reports including training and mentoring to meet current and future business needs

Preferred

Strong collaboration, interdependent partnering and influence skills

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Short- and Long-Term Disability Insurance

Business Accident Insurance

Group Legal Insurance

401(k) Retirement Plan

Pension Plan

Long-Term Incentive Program

Vacation Time

Sick Time

Holiday Pay

Work, Personal, and Family Time Off

Company

Johnson & Johnson

Glassdoor

4.2

Johnson & Johnson develops medical devices, pharmaceuticals, and consumer packaged goods.

Founded in 1886

New Brunswick, New Jersey, USA

10,001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (43)

2022 (55)

2021 (40)

2020 (30)