Associate Director, Business System Validation

Job Description

The Associate Director Business Systems Validation leads validation teams across multiple studies and programs. The individual manages performance workload and development planning for direct reports.

Responsibilities:

Validation planning strategy & readiness

• Oversee testing and validation delivery (including planning project management etc.) acting as the primary validation leader across clinical databases platform technologies data pipelines and automation tools ensuring consistency regulatory compliance and adherence to security and data protection requirements
• Lead system readiness assessments and cross-team alignment for higher-risk or multi-system initiatives ensuring end-to-end validation coverage across integrations workflows and dependent systems

Test execution defect management & issue resolution

• Proactively identify systemic validation gaps assess compliance risks and drive corrective and preventive actions to improve validation quality audit preparedness and operational performance
• Lead root cause analysis (RCA) and corrective/preventive action (CAPA) activities for complex issues identified during testing; guide teams on risk mitigation and quality improvements

Documentation compliance & continuous improvement

• Define enhance and maintain enterprise validation frameworks standards and templates in alignment with policies governance requirements and Center of Excellence guidance
• Oversee audit and inspection readiness for assigned systems and programs ensuring validation packages documentation and objective evidence meet internal QA expectations and external regulatory requirements
• Serve as a senior subject matter expert for validation best practices risk-based approaches security controls data integrity principles and compliance with SOPs (Standard Operating Procedures) and regulations and corporate policies
• Drive strategic adoption of automation frameworks AI-enabled testing solutions and validation process improvements to increase efficiency traceability and operational scalability
• Provide leadership coaching and technical oversight to junior validation staff and project teams to strengthen competencies elevate documentation quality and ensure consistent application of validation standards
• Collaborate with the Center of Excellence and platform governance bodies to ensure consistent implementation of enterprise validation models security requirements lifecycle documentation and audit-ready processes
• Lead the ongoing updating harmonization and maintenance of procedural documents including SOPs validation standards and lifecycle documentation serving as an enterprise subject matter expert

People management

• Align teams around a clear direction; set clear objectives aligned to organizational goals; assign work and set priorities accounting for work-life balance sustainability.
• Conduct regular check-ins and annual reviews; coach for performance; provide recognition.
• Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring.
• Lead recruiting and hiring and oversee performance management activities including management of sensitive employee-relations matters in partnership with HR.
• Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.
• Manage an operating budget and optimize spend against priorities.
• Inspire and ensure that team leaders are effectively supporting and empowering their individual leaders.

Technical skills

• Deep understanding of compliance and documentation standards (e.g. GxP 21 CFR Part 11 and audit traceability practices)
• Expert understanding of validation lifecycle management test governance and regulatory compliance
• Expertise in test automation frameworks AI-assisted validation tools and continuous testing within DevOps pipelines
• Deep understanding of risk-based validation documentation standards and audit traceability

Non-technical skills:

• Strong ability to lead programming teams in a matrixed global organization while ensuring delivery excellence
• Demonstrated success in coaching developing and performance-managing high-performing individuals
• Builds strong partnerships across technical business and quality functions to enhance collaboration and deliver integrated outcomes
• Balances business needs resource capacity and compliance requirements to make sound operational decisions
• Guides and reviews work across teams/geographies; builds capability and consistency; fosters inclusive high-trust culture
• Engages vendor data and industry forums; represents team professionally and credibly under pressure; maintains resilience and composure
• Operates effectively in ambiguity; drives consensus across functions; steers process/technology improvements
• Strong understanding of operations of functions

Enterprise Leadership Skills:

• Execution Excellence Is results-focused per compliance standards; sets ambitious expectations for accomplishment and ensures others contribute to org strategies by focusing them on the most critical priorities; translates departmental goals into clear expectations
• Coaching & Development Manages individual contributors and/or supervisors provides technical guidance and develops others through coaching feedback and guidance
• Entrepreneurship Embraces patient customer focus ensuring that internal or external customer perspective is the driving force behind strategic priorities business decisions org processes and individual activities; crafts and implements service practices that meet customers and own organization needs

Qualifications & experience:

• Bachelors Degree in computer science math or science with a minimum of 8 years experience working in relevant field for associated job description (System Validation Quality Assurance Testing Lead or related technical role) as well as:

• 2 years people management experience.

• Demonstrated deep subject matter expertise in relevant discipline System Validation Quality Assurance Testing Lead or related technical role.

OR

• Advanced Degree (Masters or Doctorate) in computer science math or science with a minimum of 4 years experience working in relevant field for associated job description (System Validation Quality Assurance Testing Lead or related technical role).

• 2 years people management experience.

• Demonstrated deep subject matter expertise in relevant discipline System Validation Quality Assurance Testing Lead or related technical role.

Headcount responsibility: 6 to 8

Required Skills:

Preferred Skills:

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