Head of Systems & Infrastructure Assurance, Technology Quality

Company: Johnson & Johnson
Location: Cambridge
Posted on: February 19, 2021

Job Description:

Job DescriptionJohnson and Johnson is recruiting for a(n) Head of Systems & Infrastructure Assurance, Technology Quality. The preferred location for this role is Raritan, NJ, but we will consider NJ, PA, NY, and MA. The candidate must be willing to travel to Raritan, NJ a few times a week. This position may require up to 30% travel (domestic and international).Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.With $82.1 billion in 2019 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J.TQ&C 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 Head of Systems & Infrastructure Assurance, Technology Quality is responsible for building and execution of quality into enterprise wide systems, tools, services and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, retire)* 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 individual must drive the implementation and maintenance of systems to be delivered on-time, within budget and with high quality* This individual must provide end-to-end Technology Quality leadership support to projects and base business support teams across applications and infrastructure* This individual will own the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope* Partners with Regional Leads in support of the TQ&C Operating Model* This person will be a member of the Technology Quality leadership team, and will report to VP, Technology Quality & Compliance; additionally, this individual will be part of the extended leadership teams for the areas that are supported* This role will lead globally diverse teams in an inclusive environment* This role will 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 Technology Quality & Compliance organization, requiring strong collaboration skills at the senior leadership level, and includes making recommendations for improvements relevant to senior level stakeholdersKey ResponsibilitiesBuilding and Execution of Quality into Applications and Supporting Infrastructure* Owns and manages the end-to-end quality process and strategies for building and execution of applications and supporting infrastructure across Supply Chain, Manufacturing, Laboratories, R&D, Quality Systems, ERP/WMS, Enterprise Services/Tools/Infrastructure, Data Platforms* Ensures continuous improvement is facilitated through feedback received through incidents and problem tickets* Ensures support for health authority inspections, audits (internal and external) and periodic review of applications and infrastructure in scope of the Systems & Infrastructure Assurance team * Supports the build and execution of quality into Strategic Programs across the enterprise where the use of technology supported by TQ&C is involved* Ensures/promotes early involvement of TQ&C in the design and development of applications and infrastructure to ensure automated and preventive controls are built in* Identifies measures and metrics for the quality of software/infrastructure and feedback mechanisms to ensure continuous improvement * Contributes to the creation of strategies for the qualification and validation of new and emerging technologies* Ensures that infrastructure and systems in-scope are remediated and maintained in a validated state across all segments and regions globally* Identifies potential gaps with in-scope systems, raise appropriate Non-Conformance, CAPA and drive remediation with business and IT alignment* Partners with Acquisitions, Remediation and Divestiture where applications and infrastructure are impacted to ensure risks for JNJ are mitigated* Partners with QMS leader to incorporate TQ&C related processes into the JJ Technology Quality QMS* Ensures that all Technology Quality related projects go through the Intake process* Applies comprehensive knowledge of emerging standards, regulations, guidance and industry best practices to influence and change the development of new standards to be followed by the organization* Defines internal standards and practices to move the organization toward a more proactive risk management posture by utilizing extensive knowledge of current and emerging best practices in quality risk management and quality engineering* Establishes yearly business plans for Technology Quality for respective area* Manages Project/Department budgets * Tracks and documents quantifiable business results achieved from project work and writes success stories for publication that demonstrate the business value created by TQ&CStakeholder Management* Partners with stakeholders to assess and implement compliant solutions to meet their business need* 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* Partners with key industry thought leaders and peers to influence quality in technology practices and requirements within the healthcare industry* Continually reviews external publications, regulatory guidance documents, and industry standards to ensure the quality framework for technology in healthcare business remains current and incorporates industry best practices* Participates and influences decision making in Steering Committees, Advisory Boards, Change Advisory Boards, Communities of Practice, and other relevant forumsPeople Management* Manages and leads a globally diverse team across geographies, including FTEs and contractors, within a matrixed organization* Identifies critical skills and capabilities required to ensure the development of a highly skilled, high performance team* 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 development of direct/indirect reports including training and mentoring to meet current and future business needs* Works with TQ&C leadership and pillar leaders to nurture future leaders and create opportunities to grow* Mentors talent and helps them grow in their careers* Conducts performance reviews, succession planning, talent reviews and career development for direct reportsOther Duties* Develop and maintain an effective working partnership with senior management* Collaborate with other leaders and staff within Technology Quality and Compliance group to ensure each function is executed in an efficient manner* Ensure adherence to the TQ&C Operating Model* Ensure timely reports of status, metrics and time sheets as required by the Technology Quality and Compliance organization* Ensure timely completion of assigned training and expense reports* Performs other work-related duties as assignedQualifications* A Bachelor's degree in Computer Science, Information Systems, Business Administration or another related field required. Advanced degree preferred. Solid, relevant experience may be substituted when appropriate, additional certifications a plus* A minimum of 12 years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required* A minimum of 9 years of people management experience is required* Experience in running large scale end-to-end Validation programs like LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, and Change Control is required* Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports is required* Experience establishing a new organization or group including staffing, role definitions and funding model is preferred* Life sciences industry experience is preferred* Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is required* Thorough 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 preferred * Knowledge of Software Quality Assurance and Software Quality Engineering is preferred* Certified Software Quality Engineer (CSQE), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Project Management Professional (PMP) or similar is preferred* The preferred location for this role is Raritan, NJ, but we will consider NJ, PA, NY, and MA. The candidate must be willing to travel to Raritan, NJ a few times a week. This position may require up to 30% travel (domestic and international).Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

Keywords: Johnson & Johnson, Cambridge , Head of Systems & Infrastructure Assurance, Technology Quality, Accounting, Auditing , Cambridge, Massachusetts