Lead, Technology Compliance - 2406218276W

Description

Johnson & Johnson Services Inc., a member of Johnson & Johnson's Family of Companies, is seeking a highly motivated and experienced Lead, Technology Compliance individual to join our exceptional team! While the primary location of this role is Raritan, NJ individuals can also be located at our Horsham, PA; Cincinnati, OH or Tampa, FL location.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the worlds most pressing healthcare challenges.

We know that the success of our business and our ability to deliver meaningful solutions depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

This position is responsible for supporting audit and assessment corrective actions as part of closed loop programs, including Technology Supplier Audit and GxP System Periodic Review. This role is also responsible for providing direct support to business segments during Health Authority and other Third-Party audits related to Technology areas; and compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate. This position assists in the continuous improvement of the compliance programs, including external regulatory outreach to shape emerging regulations in the areas of technology and innovative healthcare solutions!

In this role, you will play a crucial part in ensuring the flawless compliance of our technology systems and processes. As a world-class company dedicated to improving the health and well-being of people around the globe, we are looking for someone who has extensive experience in Quality and Regulatory Compliance in a regulated healthcare environment. If you are ambitious, proven in your field, and thrive in a collaborative environment, this is the opportunity for you!

Key Responsibilities:

• Leads and performs closed loop periodic reviews of J&J Segment (Innovative Medicine, Med Tech, and Enterprise) GxP computerized systems that are supported by Quality including a large global portfolio of computerized systems covering Manufacturing and Laboratory.

• Leads and performs closed loop supplier audits, covering GxP related software and service providers, including suppliers of infrastructure as a service (IaaS), Platform as a service (PaaS), Software as a Service (SaaS).

• Prepares audit reports and document observations and commitments clearly and accurately.

• Ensures timely and effective support is provided to J&J Operating Companies globally, including working with inspection site leadership to understand Quality related inspection requests and preparing domain experts to speak with investigators.

• Partners with stakeholders to assess, develop and implement solutions that enable compliant innovation. Identifies potential risks, articulates impact, and works with business partners to establish proactive risk mitigation strategies.

• Maintain awareness of new and emerging technologies and regulatory requirements.

Qualifications

Qualifications

Education:

• A minimum of a Bachelor's degree or University equivalent, required with a concentration in Computer Science, Engineering, or Life Sciences.

Experience and Skills:

Required:

• A minimum of four (4) years of experience in overseeing Quality and Regulatory Compliance in a regulated healthcare environment.

• Experience in information systems auditing within a Pharmaceutical/Medical Device company or direct experience with computerized systems.

• Knowledge of Quality System regulations, ISO, ICH, PIC/S, and cGMP regulations, including Annex 11, 21 CFR Part 11, Part 210, Part 211 and Part 820, and how these apply to Computer Systems.

• Proficient knowledge of IT internal controls, SDLC methodologies, and data integrity requirements.

• Demonstrated ability to interpret regulations and translate requirements into practical strategies.

• Excellent verbal and written communication skills.

• Ability to influence, negotiate, inspire trust, and quickly build credibility to enable the achievement of mutual goals, including solid skills in interdependent partnering to facilitate collaboration as well as partner and team coordination.

Preferred:

• Expertise in medical device software quality requirements, including standards for medical device software development and risk management.

• Audit management and delivery experience.

• In-depth compliance knowledge and experience with medical device software quality requirements.

• Experience working with Quality Management Systems.

• Experience effectively working with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc.

Other:

• This position will be located in Raritan, NJ; Horsham, PA; Cincinnati, OH or Tampa, FL and may require up to 10% domestic or international travel.

The anticipated base pay range for this position is $90,000.00 to $144,900.00.

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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys 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 of 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

This job posting is anticipated to close on October 31, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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 (https://jnjc.taleo.net/enterprise/www.careers.jnj.com) .

Primary Location NA-US-New Jersey-Raritan

Other Locations NA-US-Florida-Tampa, NA-US-Pennsylvania-Horsham, NA-US-Ohio-Cincinnati

Organization Johnson & Johnson Services Inc. (6090)

Travel Yes, 10 % of the Time

Job Function Enterprise Compliance

Req ID: 2406218276W