26 applicants

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Company

Original Job Post

Johnson & Johnson · 4 days ago

Sr Manager - Product Risk Management

Raritan, NJ

Full-time

Onsite

Senior Level

$115K/yr - $180K/yr

8+ years exp

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Health CareMedical Device

H1B Sponsorship

Comp. & Benefits

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Responsibilities

Provides leadership and oversight to ensure the use of quality principles and tools to manage and optimize the robustness and consistency for Product Risk Management (PRM) processes.

Provides strategic direction on the implementation of efficient PRM processes ensuring compliance and consistency with ICH Q9 and ISO 14971 risk management principles.

Responsible for the deployment of PRM processes within J&J Innovative Medicine and resolution of process execution challenges through collaboration with internal customers.

Leads and facilitates data-driven product risk assessments to manage potential risk during development and commercialization.

Engages in global councils and enterprise forums, ensuring PRM business needs are represented.

Leads PQM operational improvement projects through structured project management methodology.

Manages, coordinates, and provides oversight on assigned quality system processes as needed to support PQM.

Influences through others to make the case for change and builds support for proposed solutions. Coordinates and drives implementation of continuous improvement and efficiencies through building positive relationships across functions, to meet unified business objectives.

Partners with sponsors to obtain cross-functional and multi-site consensus and support for project activities, champions the usage and benefits of FPX and other project management approaches and mentors others on their effective application.

Builds trust with others and seeks to discuss difficult issues or concerns openly and respectfully.

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.

Risk assessment methodologiesRisk management principlesISO 14971ICH Q9CGMP regulationsInterpersonalPlanningPrioritizationCommunicationEnglish ProficiencyTraining DeliveryTravel Flexibility

Required

A Minimum of a Bachelor's or equivalent University degree is required with a focus in Pharmaceuticals, Chemistry, Engineering, Statistics, or other Sciences.

At minimum of 8 years of related experience in pharmaceutical, biotech, or medical device industry

Experienced in application of risk assessment methodologies

Applied knowledge of risk management principles including ISO 14971 and ICH Q9, and cGMP regulations

Strong interpersonal, planning, and prioritization skills as well as excellent written and verbal communication skills to partner effectively across different levels of our organization

Preferred

Experience crafting and delivering training across functions

Must be proficient in the English language (speak, read & write).

This position may require up to 10% domestic & international travel.

Benefits

Medical

Dental

Vision

Life insurance

Short- and long-term disability

Business accident insurance

Group legal insurance

Consolidated retirement plan (pension)

Savings plan (401(k))

Vacation up to 120 hours per calendar year

Sick time up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

Holiday pay, including Floating Holidays – up to 13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

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)