Senior Director, IT Quality, Regulatory, Compliance

WHAT YOU’LL DO 

The Sr. Director, IT Quality & Regulatory Compliance will lead the development and maintenance of a global IT quality and regulatory compliance program. This program is crucial in ensuring that our technology and data quality assurance controls align with organizational risks, comply with regulatory requirements and industry standards. The ideal candidate will have a strong background in IT quality assurance and regulatory compliance, with a keen interest in leveraging digital tools and technologies to enhance our compliance frameworks. In this role, you will collaborate with various corporate and division functions, including Quality Assurance, Regulatory, and Cybersecurity, to understand and assess both internal and external regulatory and compliance requirements. You will ensure that these controls are effectively implemented and continuously monitored to safeguard our organization's technology and data.

• Establishing and maintaining the global IT quality and regulatory compliance program, ensuring alignment with organizational risks and regulatory requirements.
• Providing vision and leadership for Quality & Regulatory compliance, maintaining a global IT quality management system, operating global quality compliance programs, providing expert consultation, building and maintaining executive relationships, and attracting and retaining talent.
• Drive continuous improvement of quality systems and processes to ensure compliance and enhance efficiency.
• Collaborate with cross-functional teams to develop and implement quality and regulatory strategies
• Maintains and operates a global IT quality management system (people, process and technology) to ensure compliance to global regulations. This includes identification and assessment of global regulations and standards that impact the organization.
• Develops strategy, processes, governance and team to support the following key processes for Abbott IT:
  • Quality & Compliance Policy and Procedure Management
  • Software Lifecycle Management and Software Quality Assurance
  • Non-Conformance / CAPA Management
  • Audit Preparation and Support
  • Third Party and Supplier Quality Management
  • Training Compliance for over 6000 employees
• Provide expert consultation to Divisional and Corporate counterparts on best practices in software quality assurance methodologies for competitive advantage. Drive continuous improvement to evolve internal practices to align with modern software development practices.
• Demonstrates exceptional relationship building with ability to leverage influence to achieve the goals of the organization.    Works with cross functional executives in Division Quality, Corporate Quality & Regulatory, SOX and Internal Audit to align on strategy and ongoing maintenance of Abbott policies and procedures.
• Build and maintain executive relationships necessary for the successful execution of the IT Quality & Regulatory compliance program. This includes developing and maintaining external and internal relationships to influence development and implementation of policies, procedures and quality assurance controls.
• Maintain strong external stakeholder relationships and proactively engage in forums to provide input into  policies and regulations that impact technology adoption and practices.
• Fluent in assessing and balancing risk with the ability to drive continuous improvement in their organization.
• Attract and retain talent, and ensure staff development (leadership, cross-functional, technical, global perspective). Promote and foster diversity.
• Manage an operating budget and project spend with financial discipline; Establish and maintain a resource model that can flex as needed.

EDUCATION AND EXPERIENCE YOU’LL BRING 

• Bachelors Degree (± 16 years) Computer Science, Engineering or related field required. MS Computer Science or MBA preferred.
• Experienced life science technology leader with domain expertise working within highly regulated markets.
• Must have experience in software validation and computer systems assurance, compliance and information security.
• 20 years of experience throughout the following environments: 
  • Quality/Compliance management in a regulated healthcare environment
  •  Software Development and Validation
  • Regulated Software Development and Validation Industry Environments
  • IT Management, Computer Science, or related field
• Requires strong analytical skills, business intelligence, effective communication, interpersonal skills, organizational intelligence, relationship management, the ability to make meaningful decisions based on sound judgement, and the ability to work effectively with a variety of roles from Executive Management to Quality Assurance Analysts.