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:

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Team Development: Build a strong, cross-functional team, fostering learning and growth opportunities.

Required Education and Experience:

• BS degree in Microbiology, Chemistry, Biochemistry, IT, or engineering

• 10-15 years of relevant IT management experience, including working with business teams, delivering IT solutions, and implementing strategic goals

• Professional experience in pharmaceutical quality, laboratory, or manufacturing operations

• Experience in Quality Assurance, Quality Control, IT, and/or Computer System Validation (CSV)

• Strong knowledge of OMS business processes and corresponding computerized systems; ORD experience is a plus

• Understanding of Data Integrity regulations and requirements

Preferred Education/Skills and Additional Qualifications:

• Demonstrated management/leadership skills

• Strong team facilitation, organization, and listening skills

• Excellent collaborative and communication skills

• Successful program/project management track record

• In-depth understanding of regulatory requirements and compliance, especially data integrity

• Comprehensive understanding of Quality activities and functions

• Experience in supporting regulatory inspections and performing audits

• Proficiency in Quality Risk Management Tools and principles

• Experience in developing and deploying effective system trainings

• Knowledge of Organon’s core business structure and Quality Management Systems

• Experience in developing and deploying innovative solutions from conceptualization to delivery

• Strong knowledge of SDLC requirements and Data Integrity industry standards

• Team leadership experience and skills

• Business and financial acumen, strategic thinking, and cross-divisional collaboration

• Ability to build relationships with senior business executives and IT solutions providers

• Strong project management, influencing, and organizational skills
• Excellent interpersonal and communication skills
• Demonstrated leadership behaviors: Ethics & Integrity, Focus on Customers, Drive Results, Build Talent, Collaborate

Secondary Language(s) Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

US and PR Residents Only

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Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.

Search Firm Representatives Please Read Carefully 
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Applicable to United States Positions Only:  Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job.  Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience.  The applicable salary range for this position in the U.S. is stated below.  Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Number of Openings: