Lead, Computer System Validation - T&DQ

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America

Job Description:

Technology & Digital Quality (T&DQ) 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.

Within Technology & Digital Quality, the IM Deployment office drives targeted strategic transformation and quality operations (CSV) initiatives aligned with the Innovative Medicine (IM) segment strategic priorities.

The Lead, Complaints / Adverse Events 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).

Ensure that all J&J quality standards and global regulatory requirements are met

Ensure building and execution activities involve early quality involvement in design and development, integrating quality into work products, implementing controls within applications/solutions, and leveraging automation when feasible

Own the quality approach for systems and hold teams accountable for delivering an end-to-end support model

Provide technical and procedural expertise/guidance to project teams, aligning with internal and external stakeholders

Plan, allocate tasks and resources, execute, coordinate, and maintain validation activities for GxP systems/applications

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 T&DQ 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

Serve as a trusted partner across the Technology & Digital Quality organization, fostering strong collaboration skills at the project team level, internally and externally

Major Duties /Approximate Percentage of Time

Tasks/Duties/Responsibilities

70% - Building and Execution of Quality into Infrastructure

Ensures/promotes early involvement of T&DQ in the design and development of applications and infrastructure to ensure automated and preventive controls are built in

Owns and manages the end-to-end quality process and strategies for building and execution of applications and supporting infrastructure

Ensures that all Quality Operations related projects go through the Intake process

Provides strategic direction and operational support to the individual project teams

Contributes to the creation of strategies for the qualification and validation of new and emerging technologies

Provides compliance guidance and support to the project teams to ensure successful delivery of the project end-to-end

Ensures a high degree of inspection readiness in support of health authority inspections, audits (internal and external) and periodic review of applications and infrastructure in scope of the T&DQ portfolio

Participates in audits, approves audit non-conformity action plans, and approves closure of internal audit findings

Assists with incident management/CAPA and NC for the systems supported

Manages the execution of technology quality tasks according to the project plan, goals and timelines

Supports the allocation of resources by accurately communicating availability

Responsible for managing resources (both internal and external) and ensuring availability for ongoing and upcoming initiatives/projects

Reviews and approves validation deliverables, such as but not limited to Compliance Plans, User Requirements/User Stories, System Tests, User Acceptance Tests, Traceability Matrices, and Compliance Reports including final release and approval for production use

Proactively monitors systems and processes to ensure compliance with standard operating procedures and industry best practices

Works with manager in developing, monitoring and managing project costs, schedules, resources and quality of work product

Assists or drives status meetings to communicate and address project risks or issues

Works collaboratively with project teams to keep them informed of project status, including any barriers

20% -Stakeholder Management

Partners with project teams to assess and implement compliant solutions to meet their business needs

Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same

Provides partnership, insight and direction to cross-functional business leaders and stakeholders regarding T&DQ policies, solutions, and initiatives

Communicates proactively with stakeholders to set expectations on the feasibility and timeframe for the delivery of solutions and highlight the risk when quality standards are not met

10%- People Management

Provides quality guidance and support to project and/or base business support teams

Utilizes expert knowledge regarding risk management practices and leads and mentors the team with critical thinking and risk-based approaches to carry out validation of computerized systems and infrastructure

Responsible for the management of consultants and outside service providers assigned to support T&DQ in project teams

Works with T&DQ leadership to nurture future leaders and create opportunities to grow

Mentors talent and helps them grow in their careers

Performs other work-related duties as assigned

100% Total

Other Duties:

•        Develop and maintain an effective working partnership with senior management

•        Collaborate with other leaders and staff within IM Deployment Office and Quality Operations group to ensure each function is executed in an efficient manner

•        Ensure timely reports of status and metrics as required by the IM Deployment Office organization

•        Ensure timely completion of assigned training and expense reports

Required Knowledge, Skills and Abilities: 

Leadership Competencies

Demonstrated leadership capabilities fostering diversity and inclusion

Strong skills in interdependent partnering and influencing `

Experience managing and leading global technology programs along with FTEs/consultant teams across multiple geographies

Ability to facilitate and communicate key messages and presentations to various cross-functional groups to gain support

Influence upwards and peers to ensure compliance and regulatory requirements are met

Make the complex clear and easily understood by others

Must have the ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands

Professional Competencies

Superior written and oral communication skills

Must have the ability to perform work with a high degree of independence in terms of self-management of a large variety of tasks and initiatives regarding quality and validation

Solutions oriented, striving for new ways to accomplish goals and pragmatic advising ensuring compliance in a cost-effective and risk-based manner

Must have the ability to work effectively in a highly matrixed team environment

Ability to manage multiple and competing projects is required

Works effectively in a virtual team environment

Core Technical Competencies

Gives input and ensures adoption for how quality will be designed into and maintained within a technology solution

Understands data integrity needed throughout the lifecycle of a technology solution

Understands traditional and emerging methods and theory of quality, including, but not limited to TQM principles, Continuous Improvement, Cost of Quality, Quality 4.0 and Industry 4.0

Defines strategy for testing according to the risk assessment

Experience in Testing Management tools like HPALM and JIRA Xray

Implements elements of an effective quality management system to the organization and its technology solution

Aware of cybersecurity and privacy principles and implications for quality and risk management activities

Applies best practices for security role design and segregation of duties within and across technology solutions

Understands how to prepare an organization and business stakeholders for audits and inspections

Able to apply digitization tools and techniques to automate, simplify, digitize and enhance software development and validation processes

Understands and applies best practices for architecting effective data solutions and frameworks that enable high quality data

Knowledge of SDLC Quality Management process and Computerized System Validation/Computerized System Assurance principles

Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is required

Working knowledge of other Global Regulations like EU Annex 11, SOX, HCC, Security & Privacy, ISO is preferred

Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable

Knowledge of Software Quality Assurance and Software Quality Engineering is highly desirable

Knowledge of the following technologies and methodologies highly desirable: Agile, SAFe, CI/CD, RPA, Cloud Storage and Computing, IoT, Data & Analytics, AI, Intelligent Automation, Blockchain, Kubernetes, XaaS, SaMD.

Project management and organizational skills are required

Degrees and Years of Experience

A bachelor’s degree in computer science, Information Systems, Business Administration or another related field required. Solid, relevant experience may be substituted when appropriate, additional certifications a plus

6+ years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required

Experience in large scale end-to-end Validation programs like LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, and Change Control is preferred

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

Proficiency using the following tools is highly desirable: JIRA, HPALM, Xray, Jenkins, Selenium

Direct experience working in a software development environment using Agile, SAFe, CI/CD or similar is desirable

Preferred Qualifications:

Preferred Minimum Education: Bachelors or Equivalent

Preferred Area of Study:  Technology-related

Preferred Related Industry Experience: Life Sciences Industry Experience

Preferred Knowledge, Skills and Abilities:

Certified Software Quality Engineer (CSQE), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Project Management Professional (PMP) or similar.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

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

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

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits