Organon -Director, QMS Delivery Lead

Job Description

Job Description

The Organon Quality IT Quality Management Systems Lead will be responsible for the operation, support, delivery, and enhancement of Organon’s IT systems supporting the Quality Business Unit. This individual should have a strong IT and business background including familiarity with core Quality Management processes such as Customer Complaints, Deviations, Change Control, Document Management, Risk Management, and Audits. This individual should have strong leadership skills and the ability to define and execute a joint IT and Business strategy related to our Quality Management Systems. The individual should have a strong background in Compliance, Computer Systems Validation, and Data Integrity and how these are implemented day-to-day in the work IT does.

As a member of the Quality & Lab IT team for Organon, this individual will lead the QMS team in defining and executing the QMS systems strategy. This will involve close partnership with a variety of different resources and management levels on the business side. This individual will need to navigate many constraints (resources, cost, timing, regulatory) in order to implement, support, and maintain the various IT systems needed to support Quality capabilities within the Organon Quality Unit. At the time of separation from our company, Organon will have a mix of stand alone and TSA’d Quality systems. This individual will need to define the strategy, approach, and timing for the TSA exits and further standup of new systems and capabilities within Organon.

This individual will lead the global QMS team and will support all Organon quality functions globally. The Organon Quality unit will be headquartered in Luzerne, Switzerland, so this position includes relocation to Switzerland.

Primary activities/responsibilities

• Stand up Quality QMS team post spin and ensure team functions to provide continuity of operational support and customer service to Organon Quality business partners.
• Create, own, implement the Quality IT QMS strategy for Organon supporting the global Quality strategy and initiatives that define near and long term business objectives.
• Directly partner with and support Quality business colleagues in definition of and execution of business strategies.
• Lead team in managing the current portfolio of IT systems within the QMS space.
• Manage software vendors for QMS systems.
• Define roadmap for QMS platforms and systems over both the near and long term horizons.
• Partner with other teams to ensure top tier support to business clients for QMS systems.
• Partner with other IT teams and platform functions to fully leverage IT services within Quality space.
• Manage team resources to execute projects to complete TSA exit strategy for Organon.
• Ensure team and project resources are fully competent and compliant with Organon SDLC and work to ensure flawless validation execution.
• Understand and react to ongoing business needs from Quality business partners.
• Lead team in ongoing development of a QMS roadmap and portfolio.
• Build strong, capable, cross functional team to provide top tier support to Organon Quality business.
• Establish strong business understanding and relationships with Quality business partners.
• Identify industry trends and look for opportunities to leverage best practices to improve solutions within our Quality systems.
• Focus on team development – both in IT and business areas. Ensure team members are given opportunities for further learning and growth within Organon.
• Provide team focus on Continuous Improvement. Work with team to identify ongoing opportunities for improvement and implement actions against these on an ongoing basis.

Requirements/Skills:

• Bachelors degree in Information Technology, Science, or Business related field
• 10-15 years relevant experience in IT management, working with business teams, building & delivering IT solutions, providing IT support, implementing IT and business strategic goals
• Working knowledge of Organon’s core business structure and how own function contributes to and works within the organization
• Experience in Quality Management Systems and associated Quality business processes
• Knowledge/experience of development and deployment of foundational & innovative solutions in any business domain from conceptualization through delivery.
• Strong working knowledge of SDLC requirements
• Strong knowledge of Data Integrity industry requirements and how they apply to IT
• Team leadership experience and skills
• Business & financial acumen
• Strategic thinking
• Ability to thinking cross-divisionally and working across boundaries
• Demonstrated ability to build relationships with senior business executives and with internal and external Healthcare and IT solutions providers.
• Project management skills
• Influencing skills
• Strong organizational skills
• Relationship management and networking: strong integration into the IT network and ability to build productive relationships with all parties
• Excellent interpersonal and communication skills
• Has demonstrated the following leadership behaviors: Ethics & Integrity, Focus on Customers, Drive Results, Build Talent, Collaborate

Our Support Functions deliver services and makes recommendations about ways to enhance our workplace and the experience of working at our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.

#NewCo

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at [email protected]
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, 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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R100680