Director - Digital, Data, AI Lead

Job Description

Interested candidates are requested to contact only the hiring manager or the recruiter for any initial information.

The Position

The Director Digital, Data, AI Lead is a key strategic role within Global Quality, responsible for maintaining and improving Quality related data and systems, including driving digital transformation of the Quality Management System. The position includes developing and implementing a comprehensive digitalization roadmap aligned with Global Quality objectives, to facilitate enhanced compliance, efficiency, and effectiveness. The role requires strong collaboration internal and external to Global Quality to define and execute business strategies, maintain and improve IT systems, and identify use cases for automation and digitalization. The Quality Data and System Lead furthermore ensures compliance to GxP standards, while enhancing the organizational knowledge of data systems, data governance, and digitalization opportunities. Through benchmarking and external awareness, the role ensures that Organon remains competitive and current to GxP standards. Additionally, the position includes supervisory responsibilities of a cross-functional team, fostering learning and growth opportunities.

Responsibilities:

1. Quality Strategy:Develop and implement the strategy for Quality related platforms and data, including a digitalization roadmap aligned with Global Quality objectives. Establish and oversee process for project prioritization.
2. Quality Systems Management:Ownership of business process, providing input and direction for Global Quality owned systems (e.g., EtQ), including roadmaps, requirements, scope, priority for improvements, and vendor engagement. Ensure availability, support, maintenance, and data security of Quality related data platforms. Support integration of data, analytics, and AI developments into Quality Management Systems to enhance decision-making, efficiency, and innovation.
3. Data Oversight:Coordinate oversight of data governance for quality-related data, to ensure the completeness and correctness of the data, enabling automation and artificial intelligence applications.
4. Business Partnership:Partner within and external to the Quality organization to define and execute business strategies, including efficient management of quality-related IT systems, and identification and implementation of new digitalization solutions. Represent the business in the cross disciplinary value teams and participate in projects and teams like DataMart, PowerBI, AI factory, and ServiceNow.
5. Compliance Activities:Support Computer System Validation (CSV) activities, maintain validated state with related SOPs, manage compliance risks (e.g., through risk assessments), monitor incidents and problems, manage related deviations and CAPAs, conduct periodic and user access reviews, and ensure change management and system inventory. Review audit reports, respond to findings, ensure GxP compliance, approve Snow Tickets, and simplify processes with QMS Process Owners.
6. Communication and Training:Develop and implement communication strategies to ensure that the Quality organization understands their role in data generation and is informed about digitalization and automation opportunities. Establish and lead a Quality data community for business process owners and data stewards to share best practices and challenges.
7. Industry Awareness:Stay informed of external developments, industry trends and best practices in quality related systems, including automation and digitalization. Benchmark to identify opportunities for improvement and innovation in the Quality organization.
8. Team Development:Build a strong, cross-functional team, fostering learning and growth opportunities.

Required Education and Experience:

1. BS degree in Microbiology, Chemistry, Biochemistry, IT, or engineering
2. 10-15 years of relevant IT management experience, including working with business teams, delivering IT solutions, and implementing strategic goals
3. Professional experience in pharmaceutical quality, laboratory, or manufacturing operations
4. Experience in Quality Assurance, Quality Control, IT, and/or Computer System Validation (CSV)
5. Strong knowledge of OMS business processes and corresponding computerized systems; ORD experience is a plus
6. Understanding of Data Integrity regulations and requirements

Preferred Education/Skills and Additional Qualifications:

1. Demonstrated management/leadership skills
2. Strong team facilitation, organization, and listening skills
3. Excellent collaborative and communication skills
4. Successful program/project management track record
5. In-depth understanding of regulatory requirements and compliance, especially data integrity
6. Comprehensive understanding of Quality activities and functions
7. Experience in supporting regulatory inspections and performing audits
8. Proficiency in Quality Risk Management Tools and principles
9. Experience in developing and deploying effective system trainings
10. Knowledge of Organons core business structure and Quality Management Systems
11. Experience in developing and deploying innovative solutions from conceptualization to delivery
12. Strong knowledge of SDLC requirements and Data Integrity industry standards
13. Team leadership experience and skills
14. Business and financial acumen, strategic thinking, and cross-divisional collaboration
15. Ability to build relationships with senior business executives and IT solutions providers
16. Strong project management, influencing, and organizational skills
17. Excellent interpersonal and communication skills
18. Demonstrated leadership behaviors: Ethics & Integrity, Focus on Customers, Drive Results, Build Talent, Collaborate

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