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Senior Manager, Acquisitions, Divestitures and Remediation, Technology Quality

$122k - $212.75k
Full-time

Johnson & Johnson Innovative Medicine

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: Quality Job Sub Function: Digital Quality Job Category: Professional All Job Posting Locations: Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America Job Description: We are searching for the best talent for a Senior Manager, Acquisitions, Divestitures and Remediation, Technology Quality to be based in Raritan, NJ; New Brunswick, NJ; or Horsham, PA. 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): Belgium - Requisition Number: R-079767 Brazil - Requisition Number: R-079763 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (View email address on click.appcast.io) or contact AskGS to be directed to your accommodation resource. 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 The anticipated base pay range for this position is : $122,000.00 - $212,750.00 Additional Description for Pay Transparency: 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)). 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 For additional general information on Company benefits, please go to: 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 Do Not Sell or Share My Personal Information Limit the Use of My Personal Information

Vacancy posted 12 hours ago
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