Description
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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Digital QualityJob Category:
ProfessionalAll Job Posting Locations:
São Paulo, BrazilJob Description:
We are searching for the best talent for a Senior Manager, Acquisitions, Divestitures and Remediation, Technology Quality to be based in Sao Paulo, Brazil.
Purpose: 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. A key function of this group is to utilize a data-driven approach to independent monitoring, to drive consistency of TQ&C processes, leading process improvements where gaps are noted.
The Senior Manager, Acquisitions, Divestitures and Remediation, Technology Quality is responsible for successful execution and implementation of acquisitions and divestitures in accordance with the defined business vision/strategy.
You will be responsible for:
Leading TQ&C strategies for Acquisitions, Divestitures and Remediation (ADR)
The role is responsible to execute the Technology Quality (TQ) strategy for J&J Acquisitions & Divestitures
This role provides day-to-day operational support to manage Acquisitions & Divestitures across the TQ organization
This position is responsible for implementing and executing the overall TQ Acquisitions & Divestiture 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
The role provides appropriate measures and monitoring for management reporting
This role will promote an environment which encourages the company’s credo and the value of a diverse workforce
This role will lead globally diverse teams in an inclusive environment
This role serves 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
This role must ensure that all J&J quality standards and global regulatory requirements are being met (e.g. 21 CFR Part 11, Annex 11)
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 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
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 be responsible for the 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.
Qualifications/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 8–10 years of progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in Computerized System Validation (CSV), particularly in acquisitions and divestitures
Strong ability to work effectively in a highly matrixed, global team environment
Strong ability to effectively and productively communicate with external and internal stakeholders
Strong cross-boundary collaboration, interdependent partnering, and influencing skills
Ability to make decisions by building and maintaining trusting, collaborative relationships to meet business needs
Proven ability to lead people and guide them through change in a complex environment
Ability to inspire trust and quickly build credibility
Excellent listening skills with the ability to incorporate diverse perspectives
Strong learning agility; demonstrates ability and willingness to continuously learn and remain current in the marketplace
Strong problem-solving skills to maintain project progress and resolve design issues
Strong executive presence, communication, and facilitation skills
Strong decision-making abilities, including decisions on quality, compliance, and management matters
Strong analytical skills
Ability to quickly understand the business being integrated or separated and related processes
Financial acumen with understanding of how services contribute to cost and/or revenue
Advanced project and portfolio management skills
Strong project management, planning, and organizational skills
Strong customer-centric mindset, with a focus on stakeholder needs and delivering service excellence (especially for new personnel during acquisitions)
High level of proactivity and resourcefulness in problem-solving
Applies design thinking methodology with a focus on end-user solutions
Strong teamwork and ability to drive toward common goals
Ability to work effectively in a virtual team environment
Strong experience in computerized system validation (CSV) in GxP environments within the pharmaceutical industry
Strong understanding of data analytics and insights
Working knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211, Part 820, and Annex 11
Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks
Strong mastery of quality-related competencies, including Quality Strategy, Applications & Infrastructure, Data Integrity, Testing, and Quality Management Systems
Advanced knowledge of security role design and segregation of duties
Familiarity with cybersecurity and privacy principles as they relate to quality and risk management
Understanding of global and regional GxP regulations
Experience with technology risk assessments
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United States - Requisition Number: R-079500
Belgium - Requisition Number: R-079767
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Required Skills:
Preferred Skills:
Compliance Management, Controls Compliance, Digital Assurance, Digital Governance, Fact-Based Decision Making, Human-Computer Relationships, Organizing, Performance Measurement, Process Optimization, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Compliance, Researching, Stakeholder Engagement, Standard Operating Procedure (SOP), Technical Credibility