Associate Director - Business/Technical Analyst - Quality Management Systems

Company: Organon & Co.
Location: Hanover
Posted on: January 22, 2023

Job Description:

Job DescriptionOrganon is a Womens Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of womens health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.Were looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.At Organon, youll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.Its going to be an exciting futurecome be a part of it!The Organon BT Quality Management Systems (QMS) Associate Director, Business /Technical Analysis colleague will be responsible for the requirements gathering, support, delivery, and enhancement management of Organons BT systems supporting the Quality Business Unit. This individual should have a familiarity with core Quality Management processes such as Customer Complaints, Deviations, Change Control, Document Management, Risk Management, and Audits. This individual should have strong business analysis and communication skills to enable the business requirements to be translated to solution requirements This individual should have strong knowledge of these relevant business solutions as well as in-depth experience in BT solution build and delivery processes. 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.As a member of the Quality & Lab BT team for Organon, this individual will work with the business on requirements for new and existing modules within the QMS technology roadmap. The role involves assisting the BT Lead in deploying new and enhanced functionality to the QMS solution. They will schedule meetings, evaluate and map business needs. Standardize processes as well as understand QMS solution capabilities. The BA will closely partner with the Quality and Compliance teams as well as BTO support within the Value Team (VT) Agile framework. Experience with Quality business processes preferred (Deviations, Document Management, CAPAs, Change Control).This individual will be part of the global QMS team and will support all Quality business functions globally. The individual should be proactive, personable, adaptable and a good communicator. The responsibilities include stakeholder management, project management, requirement gathering, supporting and troubleshooting production issues, running daily management calls.This role can be remote, working from home.Primary Responsibilities:

• Input into the 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
• Strong Business analysis skills, including documenting business and technical requirements
• Strong leadership and organization skills and demonstrated ability to help a team navigate complex issues, problem solve, and identify & implement solutions in a timely manner
• Experience working alongside developers and testers, as well as collaboration and with Quality and Compliance within the Agile VT
• Excellent facilitation and communication skills
• Perform analysis to validate business assumptions and requirements
• 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 plan the implementation of our digital QMS solution
• Strong sense of ownership
• Assist with TSA exit activities within defined timelines
• Understand SDLC and within this framework for system deliverables to ensure flawless validation execution
• Understand and react to ongoing business needs
• Work with cross functional team to provide 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 future state processes
• Work with team to identify ongoing opportunities for improvement on an ongoing basisMinimum Education Requirements:
  • Bachelor's degree or equivalent in Information Technology, Science, or Business-related fieldRequired Experience and Skills:
    • 10 years+ relevant experience in business analysis, working with business teams, building & delivering effective business processes aligned to solutions, providing IT support
    • Experience with SAFe Agile framework preferred
    • 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
    • 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
    • Strong leadership potential within the organizationWho 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 Womens 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.Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.Residents of Colorado: to request this roles pay range: email: coloradopayact@organon.comJersey City, New York City, Washington State & California Positions: to request this roles pay range and benefits, email: jcnycpay@organon.comUS and PR Residents OnlyIf you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com .For more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA SupplementOFCCP EEO SupplementOFCCP Pay Transparency RuleOrganon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.Search Firm Representatives Please Read CarefullyOrganon 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.Employee Status:RegularRelocation:No relocationVISA Sponsorship:YesTravel Requirements:25%Flexible Work Arrangements:Remote WorkShift:1st - DayValid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID: R514317

Keywords: Organon & Co., Ellicott City , Associate Director - Business/Technical Analyst - Quality Management Systems, Executive , Hanover, Maryland