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.

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 mastery of skills including, Quality Strategy, Applications and Infrastructure, Data Integrity, Quality Theory, Testing, Quality Management Systems.
Advanced knowledge of Security Role Design and Segregation of Duties.
Familiarity and awareness of cybersecurity and privacy principles and implications for quality and risk management.
Understanding of Global and Regional GxP Regulations.

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 period
10 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 validationGxP environmentsProject and Portfolio ManagementData analyticsQuality StrategyApplications and InfrastructureQuality Management SystemsSecurity Role DesignSegregation of DutiesDesign Thinking methodology

Soft Skills

Problem-solvingCommunicationFacilitationDecision-MakingListeningAnalytical skillsCustomer Centric mindsetProactivityResourcefulnessTeam collaboration

Certifications

Bachelor’s degree in Computer ScienceBachelor’s degree in Information SystemsBachelor’s degree in Business AdministrationAdvanced degree (preferred)Additional certifications (a plus)