Job 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:

Quality

Job Sub Function:

Multi-Family Quality

Job Category:

People Leader

All Job Posting Locations:

Beerse, Antwerp, Belgium

Johnson & Johnson is currently recruiting for a Director, Computerized Systems Validation (CSV) position to be located in either Raritan, NJ, Horsham, PA or Beerse, Belgium

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-077480

Belgium - Requisition Number: R-078001

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Key Responsibilities:

• 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

Qualifications

Education:

• A Bachelor’s degree in Computer Science, Information Systems, Business Administration or another related field is required; Advanced degree is preferred.

Experience and Skills:

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.

Preferred:

• Certified Software Quality Engineer (CSQE), Certified Quality Engineer (SQE), Certified Quality Auditor (SQA), Project Management Professional (PMP) or similar

Other:

• This position is on-site in a J&J location and on-site attendance is required for, at minimum, 3 days a week.

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, external applicants please contact us via https://www.jnj.com/contact-us/careers Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Budget Management, Compliance Management, Corrective and Preventive Action (CAPA), Developing Others, Inclusive Leadership, Internal Auditing, ISO 9001, Leadership, Operations Management, Performance Measurement, Quality Control (QC), Quality Processes, Quality Standards, Quality Validation, Resource Planning, Risk Management, Standard Operating Procedure (SOP), Tactical Planning

The anticipated base pay range for this position is:

€119,200.00 - €204,355.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.