Sr Mgr, Data and Platforms

About the role

Enterprise Quality (EQ) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. 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).

Responsibilities

• Guides and manages 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).
• Owns the quality approach for systems and ensures teams are accountable for delivering on an end-to end support model for systems in scope.
• Provides technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external stakeholders.
• Plays a key role in planning, task and resource allocations, executing, coordinating and maintaining the validation activities for GxP systems/applications.
• 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.
• Builds and executes quality into applications and supporting infrastructure.
• Ensures/promotes early involvement of EQ in the design and development of applications and infrastructure to ensure automated and preventive controls are built in.
• Manages the end-to-end quality process and strategies for building and execution of applications and supporting infrastructure.
• Supports the building and execution of quality into Strategic Programs across the enterprise where the use of technology supported by EQ is involved.
• 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 reviews of applications and infrastructure in scope of the EQ portfolio.
• Supports the execution of EQ tasks according to project plans, goals and timelines.
• Manages resources (both internal and external) and ensures availability for ongoing and upcoming initiatives/projects.
• Performs reviews and approval of 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.
• Tracks and documents quantifiable business results achieved from project work and writes success stories for publication that demonstrate the business value created by EQ.
• Manages Project budgets.
• Collaborates with Data & Digital Strategy team from VCO to support execution of Data & Digital Strategy roadmap data integration, governance and emerging data needs.
• Pairs with Quality Management Systems team to execute defined strategies and provides input and feedback on the efficacy of the strategy, including any recommendations for improvements.
• Pairs with the EQ organization to train and implement new strategy for improvements.
• Partners with stakeholders to assess and implement compliant solutions to meet their business need.
• Gains alignment on funding and support of the project with the Business Sponsor and/or Investment Owner.
• Communicates proactively with stakeholders to set expectations on the feasibility and timeframe for the delivery of solutions and highlight the risks when quality standards are not met.

Requirements

• Preferred Skills: Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Tactical Thinking, Team Management

Qualifications

• Education: Bachelor's degree in a relevant field (e.g., Engineering, Information Technology, Quality Management)
• Experience: Minimum of 5 years of experience in Quality Assurance or related field, preferably in a regulated industry
• Technical Skills: Strong understanding of Quality Management Systems (QMS), ISO 9001, and other relevant compliance frameworks
• Soft Skills: Excellent communication and interpersonal skills, ability to collaborate effectively with cross-functional teams, and strong problem-solving abilities

Benefits

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