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Job Description:

The AIQ Lead is responsible for the day-to-day leadership, resource management, and strategic direction of the Analytical Instrument Qualification (AIQ) team within the CAR-T Ghent organization.

The team supports both operational laboratories and project-related activities by ensuring analytical instruments remain compliant, qualified, and fit for intended use throughout their lifecycle. The AIQ Lead drives operational excellence, project execution, stakeholder engagement, and team development while ensuring compliance with Johnson & Johnson quality standards, regulatory requirements, and engineering best practices.

The role combines people leadership, operational support, project portfolio management, and technical expertise to ensure timely and high-quality delivery of AIQ services across CAR-T Ghent.

Duties & Responsibilities

People Leadership

• Leads, coaches, and develops a team of AIQ engineers and specialists.
• Conducts effective performance management, talent development, succession planning, and employee engagement activities.
• Establishes clear priorities, objectives, and performance expectations aligned with organizational goals.
• Supports recruitment, onboarding, and training of new team members.
• Promotes a culture of safety, quality, collaboration, accountability, and continuous improvement.
• Ensures adequate resource allocation and workload balancing across operational and project activities.

Operational Support

• Provides leadership for AIQ activities supporting QC and manufacturing support functions.
• Ensures timely execution of instrument qualification, periodic reviews, lifecycle management, and compliance activities.
• Acts as escalation point for complex operational issues and quality-related concerns.
• Collaborates closely with Operations, QC, QA, Engineering, and other stakeholders to prioritize and execute AIQ activities.
• Drives continuous improvement initiatives to enhance efficiency, standardization, compliance, and customer satisfaction.
• Supports audit readiness and inspection preparedness for all AIQ-related activities.

Project Portfolio Management

• Oversees project planning, prioritization, resource forecasting, and execution of multiple concurrent projects.
• Ensures project deliverables are completed on scope, schedule, budget, and quality expectations.
• Provides strategic direction for critical and complex AIQ projects.
• Reviews project risks and develops mitigation plans together with project teams and stakeholders.
• Tracks and reports project performance, resource utilization, and portfolio metrics.

Stakeholder Management

• Builds strong partnerships with customers, project teams, quality organizations, and management.
• Conducts regular customer alignment meetings to understand business needs and ensure AIQ activities remain aligned with operational priorities.
• Serves as primary AIQ representative within cross-functional initiatives.
• Communicates project statuses, risks, opportunities, and strategic recommendations to leadership.

Compliance & Quality

• Ensures compliance with Johnson & Johnson standards, GMP requirements, corporate procedures, and regulatory expectations.
• Ensures AIQ processes, qualification documentation, and engineering practices are inspection-ready.
• Supports investigations, CAPAs, change controls, and quality improvement initiatives.
• Champions data integrity and quality culture within the organization.

Qualifications

Education

• Bachelor's, Master's, or equivalent degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical field.

Experience

• Minimum 7-10 years of experience in pharmaceutical, biotech, manufacturing, laboratory, validation, or engineering environments.
• Demonstrated experience leading technical teams and managing complex projects.
• Experience with qualification and lifecycle management of analytical laboratory equipment and computerized systems.
• Strong knowledge of GMP, qualification and validation principles.

Preferred

• Experience within Cell & Gene Therapy or Advanced Therapies.
• Experience managing multidisciplinary engineering project portfolios.
• Knowledge of AIQ lifecycle management, data integrity, computerized systems, and laboratory operations.

Leadership Competencies

• Strong people leadership and coaching skills.
• Strategic thinking and decision-making capability.
• Excellent stakeholder management and influencing skills.
• Strong planning and organizational skills.
• Ability to manage competing priorities in a dynamic operational environment.
• Effective verbal and written communication skills.

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Required Skills:

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The anticipated base pay range for this position is:

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.