Leading TQ&C strategies for Separation of Depuy-Synthes business and related GxP Computerized Systems.
Execute the Technology Quality (TQ) strategy for the Separation.
Provide day-to-day operational support to manage Separation across the TQ organization.
Implementing and executing the overall TQ Separation strategy and framework to include an assessment of IT systems for acquired businesses and developing a streamlined approach for divesting IT systems within the defined Quality Management Framework.
Provide appropriate measures and monitoring for management reporting.
Promote an environment which encourages the company’s credo and the value of a diverse workforce.
Lead globally diverse teams in an inclusive environment.
Serve as a trusted partner across the Technology Quality & Compliance organization, requiring strong collaboration skills at various levels within and outside the organization, and includes making recommendations for improvements relevant to senior level stakeholders.
Ensure that all J&J quality standards and global regulatory requirements are being met (e.g. 21 CFR Part 11, Annex 11).
Ensure 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.
Own the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope.
Provide technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external stakeholders.
Planning, task and resource allocations, executing, coordinating and maintaining the validation activities for GxP systems/applications.
Approval of SDLC / Validation documentation deliverables including the approval to release system implementation and/or changes for production use, will attend project team meetings and provide TQ&C compliance guidance.
Defining and Managing the Acquisitions, Divestitures and Remediation Operating Model: Responsible for executing and implementing the strategy and framework for TQ assessments of IT systems, e.g. infrastructure, applications and healthcare technology systems separated from J&J.
Responsible for executing separation activities of the GxP systems: Manufacturing, Lab, R&D, Infrastructure, IT Tools, Websites, Mobile Applications, Software as a Medical Device (SAMD), Supply Chain.
Ensure/promote early involvement of TQ&C in the design and development of applications and infrastructure to ensure automated and preventive controls are built in.
Manage the end-to-end quality process and strategies for building and execution of applications and supporting infrastructure.
As a Power User, ensure that all Technology Quality related projects go through the Intake process & manage budgets effectively to deliver values to business (Legal Entities Separations for Day 1, TSA etc).
Provide strategic direction and operational support to the individual project teams.
Responsible for implementing and maintaining TQ separation metrics and reporting for TQ infrastructure, application, healthcare related activities.
Provide compliance guidance and support to the project teams to ensure successful delivery of the project end-to-end.
Ensure 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 TQ&C portfolio.
Participate in audits, approves audit non-conformity action plans, and approve closure of internal audit findings.
Assist with incident management/CAPA and NC for the systems supported.
Manage the execution of TQ tasks according to the project plan, goals and timelines.
Support the allocation of resources by accurately communicating availability.
Responsible for managing resources (both internal and external) and ensures availability for ongoing and upcoming initiatives/projects.
Perform review 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 the Compliance Reports including final release and approval for production use.
Lead/work with TQ&C Deployment Office representatives on the separation activities.
Proactively monitor systems and processes to ensure compliance with standard operating procedures and industry best practices.
Track and document quantifiable business results achieved from project work and write success stories for publication that demonstrate the business value created by TQ&C.
Recognize and respond to stakeholder needs and ensure commitments are delivered upon.
Provide partnership, insight and direction to cross-functional business leaders and stakeholders regarding TQ policies, solutions and initiatives.
Build and maintain trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and help others to do the same.
Manage relationships with the New Company TQ&C leaders and their teams to ensure seamless delivery of compliant separated systems to the new company. This includes but not limited to complete/accurate validation package, process/tools & resources for ongoing support (post integration).
Manage relationships with Regulatory Compliance, Business Quality Operations and Business Quality Assurance, J&J Technology, R&D Quality, Information Security Risk Management, Worldwide Records Information Management, Privacy, etc. for the separated business segment, globally.
Apply comprehensive risk management approaches and Quality and Compliance Principles to address and propose mitigation for risks associated with Separation to new company, including Due Diligences.
Utilize expert knowledge of quality risk management practices and lead and mentor the team with critical thinking and risk-based approaches to carry out validation of computerized systems and infrastructure, especially with reference to Separation/Divestiture and complexities (technology vs business processes). e.g. Defining overall validation and test strategies for acquiring systems, monitor risks throughout the execution, implement/test mitigations and/or workarounds.
Proactively monitor/uncover any potential risks and partner with stakeholders on potential solutions; adopt quality processes (such as NC/CAPA) for deviations and defect management.

Requirements

A Bachelor’s degree in Computer Science, Information Systems, Business Administration or other related field required; advanced degree preferred; solid, relevant experience may be substituted when appropriate; additional certifications a plus.
A minimum of 10-12 years of progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in Computerized System validation activities specifically in the areas of acquisitions and divestitures.
3+ years of experience managing people.
Strong problem-solving skills to assist in maintaining project progress and on design issues.
Strong executive presence, communication and facilitation skills.
Strong Decision-Making abilities, required to make decisions on quality and compliance issues as well as, management items.
Excellent listening and analytical skills.
Advanced Project and Portfolio Management Skills.
Strong Customer Centric mindset, understands one’s stakeholders and their needs and priorities and can drive service excellence by focusing on customer value particularly for new personnel joining J&J.
Strong level of proactivity and resourcefulness to solve problems.
Applies Design Thinking methodology, emphasizes the end user to ideate possible solutions.
Strong ability to team with others and drive towards a common goal.
Works effectively in a virtual team environment.
Strong experience in computer systems validation in GxP environments in the pharmaceutical industry required.
Strong understanding of data analytics.
Working knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820, Annex 11 required.
Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable.
Strong Experience of data analytics and Insights.
Working Knowledge with Technology Risk Assessments.

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)).
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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Computerized System ValidationProject ManagementData AnalyticsQuality Risk ManagementGxP ComplianceSDLCGAMP 5ITILDesign ThinkingValidation Documentation

Soft Skills

Problem-SolvingCommunicationDecision-MakingAnalytical SkillsCustomer CentricityProactivityCollaborationLeadershipFacilitationListening

Certifications

Bachelor's Degree in Computer ScienceBachelor's Degree in Information SystemsBachelor's Degree in Business AdministrationAdvanced Degree (preferred)Relevant Certifications