Associate Director, Technology Quality Assurance
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 future—come be a part of it!
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Associate Director of Technology Quality Assurance will be responsible for the Quality oversight of good practices (GxP) computerized solutions in accordance with applicable Organon procedures and policies as governed by the Quality Manual and global regulations.
This position will work directly with Business Process Owners, Data Owners and Technology Support & Delivery services over the life cycle of the system. The incumbent will support the preparation, review, and approval of documentation related to validation and quality operation of computerized systems including core requirements, policies, guidelines, SOPs, quality alerts, quality bulletins, white papers, best practices, flow charts, and training with the focus on driving consistency of requirements and system functionality across global organizations.
The successful candidate will demonstrate mastery in key core competencies around leadership and teamwork, communication, problem solving and decision-making, conflict resolution, and accountable for sound decisions by possessing a thorough understanding of Computer System Validation, industry regulation and IT operations.
Drive strategy and continuous process improvement and validation across all enterprise quality management system capabilities
Internal/external entities to evaluate, assess, identify, install and maintain technologies aligned with Organon Quality strategic objectives.
Provide quality & compliance consultancy and expertise to Global Quality Organization, IT and Organon colleagues.
Facilitate/manage multiple ad-hoc initiatives and general operational activities.
Monitor/Report service metrics (SLAs).
Provide technical consultation/expertise/inputs to capability owners and Global Quality Organization.
Managing employees and contractors. Serves as a role model, mentor for direct reports and shares knowledge within and across functions.
Interfaces with functional area representatives as well as groups to ensure timely execution of project activities, including anticipating and identifying project risks, mitigations, and contingencies as well as supporting timely action plans and issue resolution.
Monitor and communicate any decisions, proposed changes or recommendations that have a significant impact to deliverables, timelines and/or approach to the appropriate cross-functional team members and/or leadership forums.
Education Minimum Requirements:
B.S or B.A – In Science, Pharmacy, Computer Science, Business Administration.
Preferred- Master's or equivalent degree in pharmaceutical manufacturing or Business Administration.
Required Experience and Skills:
Minimum 7 years of experience working in a quality and/or compliance oversight role in the pharmaceutical/biotech industry.
3 years of experience in delivering validated IT solutions or an application support role.
Must demonstrate extensive knowledge of the principles, theories and concepts of computerized system validation for compliance to GxP regulations, including data integrity requirements, and SOP writing.
Prior experience with employee management
Familiarity and practical experience in the implementation of quality systems in a pharmaceutical or biotechnology manufacturing environment.
Must be self-driven, proactive, work with minimal supervision and possess good communication skills to interact across all levels.
Preferred Experience and Skills:
Good understanding of Technology Operations.
Six-Sigma Green Belt Certification.
Prior experience with Medical Device
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.
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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.
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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.
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.10%
Flexible Work Arrangements:Remote Work, Telecommuting, Work Week
Valid Driving License:
Number of Openings:1