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!
About the role
Organon is hiring an Associate Director of GMP Technology Audits to join our team that will report to the GMP Technology Audit Lead.
In this role, you’ll be responsible for the execution and operation of the Internal Audit and Vendor Assessment programs within Organon’s Manufacturing & Supply organization (OMS).
This position will implement a risk-based approach to ensure required controls are implemented for GMP computerized systems that could potentially affect patient safety, product quality, and data integrity.
This is a great time to join our OMS organization as it grows and evolves. In this role you will drive continuous improvement by proactively identifying quality and compliance exposures and tracking remediation opportunities.
Role Responsibilities :
Lead internal audits of computerized systems including both enterprise and manufacturing site systems; and External audits of suppliers providing software and technology services to OMS.
Collaborate with key stakeholders such as Global Quality and Compliance, Technology Quality Assurance, BT, CISO, Procurement, Engineering, and Organon’s manufacturing sites.
Ensure a risk-based approach towards profiling and selecting internal and external (vendor) audits / assessments.
Develop and maintain procedures to deliver audit programs.
Manage overall internal and vendor audit and assessment plans, schedules, communications, and stakeholder expectations
Deliver audit reports and manage escalations and visibility of audits and assessment outcomes
Provide quality & compliance consultancy and expertise to GQ, BT, and OMS colleagues
Provide training delivery for audit and assessment programs
Identify and implement continuous improvement opportunities
Liaise with other GQ audit and compliance groups and Corporate Internal Audit to coordinate audit schedule and agree on audit scope criteria
Manage multiple projects / ongoing work activities of high complexity within GQ and across OMS divisions
Mentor junior audit staff as appropriate
Monitor quality metrics and audit trends, identify compliance issues, and determine opportunities for quality improvements within GQ customer areas.
Responsible for practical knowledge of current and emerging global guidelines and regulations, relevant regulatory approaches, and actions to effectively develop and advance audit strategies.
Role Requirements :
Bachelor's degree in Science, Information Technology, or equivalent IT experience related to IT Systems Development, Implementation and / or IT Operations within a regulated environment.
5-7 years of auditing experience in a highly regulated environment. Extensive knowledge of the principles, theories, and concepts of computerized system validation, computer software assurance, and auditing for compliance with GMP regulations
Experience in delivering validated IT solutions or in an application support role
Familiarity and practical experience in the implementation of quality systems in a pharmaceutical or biotechnology manufacturing environment.
Experience in a management role with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
Good understanding of technology operations
CISA, CISSP Certification and knowledge of frameworks established under COBIT and ITIL