Manager - TQC New Health Platforms
Company: J&J Family of Companies
Posted on: March 19, 2023
Manager - TQC New Health Platforms - 2306107586W
Johnson & Johnson Services, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Manager, TQC New Health Platforms in Raritan, NJ! Remote work options may be considered on a case-by-case basis and if approved by the Company.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.
With $94.9 billion in 2022 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Technology Quality and Compliance (TQ&C) leads the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions.
The Manager New Health Platforms ensures compliance of medical device software (SaMD) and product hosting infrastructure across the enterprise in accordance with internal policies, procedures and external regulations.
Responsible for supporting the project team through the day-to-day project activities under the supervision and direction of function head.
In conjunction with franchise quality assurance teams, provides quality oversight in support of engineering, release and post-market support activities for:
SaMD - Standalone software medical devices (i.e. mobile, wearables, web applications)
Hardware integrated solutions such as software enabled surgery systems (robotics)
Digital manufacturing and 3D printing
Medical device infrastructure, including IaaS and internal hosting of product software
This position is also responsible for providing regulatory compliance expertise and supporting any compliance related remediation efforts
Reviews/approves validation documentation work such as but not limited to Compliance Plans, User Requirements, System Tests, User Acceptance Tests, Traceability Matrices, and Compliance Reports including final release and approval for production use
Ensures outstanding Inspection Readiness for Systems in software medical device portfolio, with the purpose of minimizing the risk of inspection observations to business systems/infrastructure
EDUCATION & EXPERIENCE:
A minimum of a Bachelor's or equivalent University degree required focused degree in Computer Science, Information Systems, Business Administration or other related field preferred; additional certifications a plus
A minimum of 8 years of dynamic experience in the pharmaceutical, medical device or biotech industry, with direct hands on experience in healthcare technology quality management
Must have the ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands
Leads a team of external resources through the system lifecycle and utilizes expert knowledge regarding risk management practices
Demonstrable skills in interdependent partnering and influencing required
This role serves as a trusted partner across the organization, requiring strong collaboration skills at the senior leadership level, and includes making recommendations for improvements relevant to senior level partners
Outstanding written and verbal communication in a multi-functional setting, and able to work with a high degree of independence and self-management
Provides an environment which encourages the company's credo, dedication to equal employment opportunity and the value of a diverse work force
Outstanding problem-solving skills to assist in maintaining project progress and on design issues
Excellent intellect, strategic and big picture thinking ability, complemented by operational and business planning orientation
Experience in authoring or reviewing validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans and Reports
Solid experience and knowledge working with regulations and standards such as 21 CFR 820, ISO 13485, etc.
Solid understanding of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable
Strong analytical skills with experience in GxP computerized system validation
Works effectively in teams that are not geographically co-located
CORE TECHNICAL PROFICIENCIES:
Experience with medical device software, including standalone systems
Experience with integrated hardware projects such as robotics and 3D printing platforms
Experience with infrastructure qualification and quality assurance activities for both internal and hosted platforms
Experience in Testing Management Tools like JIRA/qTest is required
This position may require up to 10% travel
The anticipated base pay range for this position is $ 97,000 to $166,750.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits
- 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
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com (http://www.careers.jnj.com)
Primary Location NA-US-New Jersey-Raritan
Other Locations NA-United States
Organization Johnson & Johnson Services Inc. (6090)
Relocation Eligible: No
Travel Yes, 10 % of the Time
Job Function Quality Systems
Req ID: 2306107586W
Manager - TQC New Health Platforms - 2306107586W
Keywords: J&J Family of Companies, Trenton , Manager - TQC New Health Platforms, Executive , Trenton, New Jersey
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