Associate Director - Business/Technical Analyst - Quality Management Systems
Company: Organon & Co
Location: Panama City
Posted on: January 23, 2023
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Job Description:
Job Description
Organon is a Women's 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
women's 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.
We're 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, you'll 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.
It's 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 Organon's 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 basis
Minimum Education Requirements:
* Bachelor's degree or equivalent in Information Technology,
Science, or Business-related field
Required 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 organization
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.
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 role's pay range: email:
coloradopayact@organon.com
Jersey City, New York City, Washington State & California
Positions: to request this role's pay range and benefits, email:
jcnycpay@organon.com
US and PR Residents Only
If 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 Poster
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
Organon is an equal opportunity employer,
Minority/Female/Disability/Veteran - proudly embracing diversity in
all of its manifestations.
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.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Yes
Travel Requirements:
25%
Flexible Work Arrangements:
Remote Work
Shift:
1st - Day
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Keywords: Organon & Co, Tallahassee , Associate Director - Business/Technical Analyst - Quality Management Systems, Executive , Panama City, Florida
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