Director, Computerized Systems Validation (CSV)
About The Position
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. 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. The role provides TQ&C expertise/guidance to the project teams. 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 cloud infrastructure. This individual will lead 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 role will lead global teams with unique skills in cross-functional environments. 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 collaboration skills at the senior leadership level, both internally and externally.
Requirements
- A Bachelor’s degree in Computer Science, Information Systems, Business Administration or another related field is required.
- 10-12 years of experience leading GxP computerized systems validation (CSV) within pharmaceutical, medical device, biotech industry, or other regulated industries.
- Deep understanding of GxP regulations and compliance requirements, including data integrity, SDLC governance, validation lifecycle managements, electronic records/signatures, audit trails, and inspection readiness.
- Thorough knowledge of global cGMP regulations and computerized systems requirements including: 21 CFR Part 11, 21 CFR Part 210 and 211, 21 CFR Part 820, EU Annex 11, Emerging Annex 22 expectations, Data integrity guidance, Risk-based validation and Computer Software Assurance (CSA) principles.
- Proven experience providing Quality and Compliance oversight for large scale ERP platform implementations, upgrades, integrations, and lifecycle management activities within regulated environments.
- Strong knowledge of ERP ecosystems supporting Finance, Supply Chain, Manufacturing, Procurement, Quality, Warehouse Management, and Planning functions.
- Experience leading risk-based validation strategies, and compliance activities for enterprise ERP platforms and supporting digital ecosystems.
- Strong experience with Computer System Validation (CSV), Computer Software Assurance (CSA), change control, deviation management, CAPAs, periodic reviews, and validation governance processes.
- Experience overseeing validation deliverables and compliance activities associated with ERP implementations including intended use, risk assessments, requirement traceability testing strategies, defect management, and validation summary reporting.
- Direct experience supporting regulatory inspection, internal audits, supplier audits, and health authority inspection involving GxP computerized systems and ERP platforms.
- Demonstrated people leadership experience managing and developing global, matrixed, and geographically distributed teams.
- Experience leading organizational development activities including hiring, performance management, coaching, mentoring, succession planning, talent development, resource management, and organizational capability building.
- Strong executive presence with ability to influence and collaborate with senior business, Quality, and technology leaders across global organizations.
- Proven experience managing multi-million-dollar platform implementation and operational budgets, including financial planning, forecasting, and cost optimization.
- Experience leveraging automation, advanced analytics, AI-enabled technologies, and digital capability to improve validation efficiency, and operational performance.
- Understanding of cybersecurity, privacy, and digital risk management principles and their impact on GxP quality systems, validation activities, and regulator technology platforms.
- Experience applying security role design, role-based access controls (RBAC), and segregation of duties principles across enterprise technology platforms, and integrated digital ecosystems.
Nice To Haves
- Advanced degree is preferred.
- Certified Software Quality Engineer (CSQE), Certified Quality Engineer (SQE), Certified Quality Auditor (SQA), Project Management Professional (PMP) or similar.
Responsibilities
- Ensure that all J&J quality standards and global regulatory requirements are being met.
- 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.
- Provide TQ&C expertise/guidance to the project teams.
- Drive the implementation and maintenance of systems to be delivered on time, within budget and with high quality.
- Provide end-to-end Technology Quality leadership support to projects and base business support teams across applications and cloud infrastructure.
- Lead the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope.
- Partner with Regional Leads in support of the TQ&C Operating Model.
- Lead global teams with unique skills in cross-functional environments.
- Provide an environment which encourages the company’s credo and the value of a diverse workforce.
- Serve as a trusted partner across the Technology Quality & Compliance organization, requiring collaboration skills at the senior leadership level, both internally and externally.
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
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
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What This Job Offers
Job Type
Full-time
Career Level
Director
