Sr Manager, Data and Platforms

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 ;br>
Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
People Leader

All Job Posting Locations:
Horsham, Pennsylvania, United States of America

Job Description:

Johnson & Johnson is recruiting for a Sr Manager, Data and Platforms, located in Raritan, NJ, Horsham, PA or Zug, Switzerland!

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 ;br>
Enterprise Quality (EQ) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. EQ is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with J&J's Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with closing compliance gaps related to audits and inspections.

The Leader of Systems & Infrastructure Assurance (Data Platforms), Enterprise Quality 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).
Key Responsibilities:

• This role must ensure that all J&J quality standards and global regulatory requirements are being met
• This role ensures that building and execution activities include 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 whenever feasible
• This candidate will lead the quality approach for systems and ensure teams are accountable for delivering on an end-to end support model for systems in scope
• The role provides technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external stakeholders
• The role is responsible for planning, task and resource allocations, executing, coordinating and maintaining the validation activities for GxP systems/applications
• This position will support internal audits and Health Authority regulatory inspections
• This candidate will be responsible for the approval of SDLC validation documentation work including the approval to release system implementation and/or changes for production use, will attend project team meetings and provide EQ quality and compliance mentorship and support to project and base business support team members
• This role will lead globally diverse teams in an inclusive environment and provide an environment which encourages the company's credo and the value of a diverse workforce.
• This role serves as a trusted partner across the Enterprise Quality organization, requiring strong collaboration skills at the senior leadership level, and includes making recommendations for improvements relevant to senior level stakeholders
• Sets vision 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 EQM 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, JIRA with Xray, Selenium
• Implements elements of an effective quality management system to the organization and its technology solutions
• Aware of cybersecurity and privacy principles and implications for quality and risk management activities
• Applies standard methodologies 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
• 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

Qualifications

Education:

• A minimum of 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

Experience and Skills:

Required:

• A minimum of 8 years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required
• At least 3 years experience as a people manager
• 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
• Experience managing and leading global technology programs along with FTEs/consultant teams across multiple geographies
• Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is required
• 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 an efficient 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

Preferred:

• Experience in running large scale end-to-end Validation programs like LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, and Change Control is preferred
• Solid understanding of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable
• Working knowledge of other Global Regulations like EU Annex 11, SOX, HCC, Security & Privacy, ISO is preferred
• Direct experience working in a software development environment using Agile, SAFe, CI/CD is highly desirable
• Knowledge of Software Quality Assurance and Software Quality Engineering is highly desirable

Other:

• This position is anticipated to have up to 15% travel, both domestic and international

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ;br>
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :
$120,000-$207,000

Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are 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. 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)). 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 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 Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below.