Job Function: Quality
Job Sub Function: Quality Control
Job Category:People Leader
All Job Posting Locations:Irvine, California, United States of America
Job Description:We are searching for the best talent for a
Senior Manager, Q&C Acquisitions and Divestitures (PMO) located in Irvine, CA. This is a duration-based project expected to conclude on June 30, 2028.
About MedTechFueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
Purpose: Responsible for projects within MedTech (MT) Q&C Acquisitions and Divestitures (A&D), which include A&D assessment, investigation (due diligence/reverse due diligence), and Integration/Separation planning and execution. Responsible for shaping, architecting, and delivering the PMO separation strategy for the Atraverse Medical integration. This role will ensure continuity of quality processes and regulatory compliance during integration. It will coordinate global teams to map and define dispositions for processes, documents and systems, and drive the implementation of Quality applications required for Atraverse to operate as part of J&J.
The role is a senior program leadership position requiring cross-functional influence, regulatory understanding, deep Quality Systems experience, and the ability to lead organizational change in a regulated environment while minimizing risk to product supply and patient safety. The leader shall work in collaboration with other functions, such as Regulatory Affairs and Supply Chain, and with other Quality Workstreams, to resolve interdependencies and ensure aligned handovers.
You will be responsible for:- Support the Q&C A&D PMO leader with the following:
- Integration/separation strategy and plans for assigned MT A&D projects, including end-state configuration, operating model, and timing.
- Develop budgets for the immediate business needs and the long-term integration needs.
- Maintaining Q&C A&D Playbook and tools with the latest thinking and templates.
- Drive PMO quality activities
- Provide leadership and mentorship to PMO and other workstream teams and build a high-performing community of practice across regions and workstreams.
- Coach Q&C A&D personnel in the use of Q&C A&D Standard and Playbooks across all stages of Integration or Separation.
- Provide Project Management Support for individual project Integrations or Separations.
- Work with project teams to develop an Integration or Separation Dashboard to report Q&C A&D commitments against the deal model.
- Support Q&C A&D leader in identifying priorities, progress, and risks associated with Value Creators, Risk Mitigations, and End State Q&C Operating Model for Integrations and Separations.
- Works with the Q&C A&D team to gather Lessons Learned and identify best practices based on each deal worked on and participated in.
- Understand and effectively manage budgetary requirements.
- Responsible for ensuring MT Q&C A&D personnel and MT Q&C comply with all Federal, State, local, and Company regulations, policies, and procedures.
- Performs other assigned duties as needed.
This role offers a unique learning and development experience by:
- Leading a complex, cross-company integration and gaining deep hands-on experience in regulatory transitions.
- Working directly with senior leaders across Quality, Regulatory, IT and Supply Chain.
- Building a broad cross-functional network and collaborate with subject-matter experts across multiple geographies and functions.
- Accelerating your career by owning high-impact deliverables that demonstrate program leadership, technical judgment and stakeholder influence.
- Gaining global exposure through multi-site coordination, regulatory interactions and travel as required.
Qualifications/Requirements:- An undergraduate degree in Engineering, Science, Business or Business Management, or Quality Systems Management is required. A graduate degree is preferred but not required.
- Minimum of 5 years of related work experience; 2+ years of leadership experience in Quality Assurance within Medical Device, Diagnostic, Pharmaceutical, or other regulated industries.
- 1+ years leading A&D deals preferred (i.e., due diligence, integration/separation planning, or execution).
- Project Management experience is required.
- Experience in international Medical Device regulations is preferred.
- Knowledge and experience in A&D transactions.
- Cross-functional (matrix) project management expertise with some strategy development, planning, and corresponding measurable business results.
- Understanding the interdependence of product development, manufacturing, and delivery to the customer.
- Demonstrated track record of creating and maintaining strong relationships across multiple disciplines.
- Driving alignment and consensus with project teams; ability to achieve results collaboratively.
- Leadership across diverse organizations in terms of scope, experience, and geographic presence.
- Demonstrated success in managing complexity.
- Knowledge of FDA Quality System Regulation and ISO 13485 Standard is required.
- Critical thinking and investigative skills are required.
Eligibility for severance.
Required Skills:Preferred Skills:Compliance Management, Corrective and Preventive Action (CAPA), Developing Others, Human-Computer Relationships, Inclusive Leadership, Leadership, Operational Excellence, Performance Measurement, Product Testing, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Quality Validation, Standard Operating Procedure (SOP), Tactical Planning, Team Management
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: - https://www.careers.jnj.com/employee-benefits
