Job Description

The Position

The Organon Business Technology (BT) Quality Management Systems (QMS) Specialist, Business /Technical Analysis colleague will be responsible for providing support and business/technical analysis efforts for the Organon QMS platform, including requirements gathering, support, delivery, and enhancement management.

This individual should have a familiarity with core Quality Management processes as well as BT core processes such as change management, service management, SDLC, and incident management.  This individual should understand analytics/AI relating to supporting and driving efficiencies in processes. This individual should have strong collaboration and communication skills to work with business clients, our service management team, and our vendor(s) to provide best possible responses and services to our business clients.

The individual should have experience with Compliance, Computer Systems Validation, and Data Integrity and how these are implemented day-to-day in the work BT does to deliver and support BT platforms for the business.  This individual will work closely with the QMS Platform Lead and the Agile delivery teams in the overall management, delivery, and support of our QMS platforms. 

Responsibilities

The primary responsibilities of this individual will be to assist the platform lead and QMS Product Owner in managing the following aspects of our QMS BT Platform:

New capability / module delivery

Support for agile delivery teams

Analytics/AI/Automation opportunities

Partnering with other team members for requirements definition and new solution builds

Business communication / governance

As a member of the Quality & Lab BT team for Organon, this individual will work closely with the business and other members within BT to ensure that the QMS platform is maintained and providing the required capability to the business.  This includes facilitating the proper uptime, managing upgrades/releases, managing support, partnering with the vendor, and working with the other team BT leads to support build and deliver new capabilities within the system.  Experience with Quality business processes preferred (Deviations, Document Management, CAPAs, Change Control).  Agile delivery experience and understanding is also preferred.

The individual should be proactive, personable, adaptable and a good communicator. The responsibilities include stakeholder management, project management, solution management, business / vendor management, and supporting and troubleshooting production issues, running daily management calls. This role can be remote, working from home.

This individual will be part of the global QMS team and will support all Quality business functions globally. 

Partner with other teams to ensure top tier support to business clients for QMS systems.

Partner with other team members to manage the QMS platform day to day – including delivery and support

Establish metrics for support and overall platform operations

Strong Business analysis skills, including documenting business and technical requirements.

Experience working alongside developers and testers, as well as collaboration and with Quality and Compliance

Analytics/AI/ Automation experience preferred

Excellent facilitation and communication skills

Supports effective business analysis through analytical thinking, problem-solving and communication skills

Work closely with members of our delivery team, including stakeholders, development and Quality & compliance teams to implement new solutions and updates to our current QMS solutions

Strong sense of ownership

Understand SDLC and within this framework for system deliverables to ensure flawless validation execution.

Establish strong business understanding and relationships with Quality business partners.

Work with team to identify ongoing opportunities for improvement on an ongoing basis.

Required Education, Experience, and Skills   
Bachelor’s degree or equivalent in Information Technology, Science, or Business-related field

At least 2 years relevant experience in business analysis, working with business teams, building & delivering effective business processes aligned to solutions, providing IT support.

Knowledge of core Quality business processes

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

Preferred Education, Experience, and Skills

Familiarity / experience with Agile solution delivery (SAFe) is a plus. 

Other

Team collaboration experience and skills

Strategic thinking

Ability to thinking cross-divisionally and working across boundaries

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 behaviours: Ethics & Integrity, Focus on Customers, Drive Results, Build Talent, Collaborate

Secondary 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.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. 

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. 

Annualized Salary Range

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:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R528756