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Associate Director Quality Management Systems, EtQ Business Owner

4 months ago

Cramlington, United Kingdom Organon Full time

Job Description

We are hiring EtQ Business Owner, who will be responsible for the availability, support, and maintenance of EtQ, and for the security of the data residing within that system.

In this role you will be ensuring that the EtQ application and its operation are in compliance and fit for intended use in accordance with the associated GMP/GDP process Standard Operating Procedures (SOPs).

You will interact with the Global Process Owners, Site Process Subject Matter Experts (SMEs) and users to represent their needs.

Responsibilities

  • Support the development and execution of the EtQ Roadmap.

  • Develop Requirements, Scope, and Priority for improvements / enhancements.

  • Vendor engagement to provide voice of the customer.

  • Computer System Validation (CSV) activities for the platform and modules with Process Owners

  • Procedures related to System use and maintaining a validated state ensuring that SOPs required for maintenance of the system exist and are followed.

  • Identify and Manage Compliance Risks with the EtQ system using Failure Mode Effects Analysis (FMEA).

  • Trend Monitoring of platform/module incidents and problems

  • Management of Deviations and Corrective and Preventive Actions (CAPAs) for the EtQ system.

  • Periodic Reviews and User Access Reviews for the system

  • Ensuring changes are managed.

  • Ensuring the availability of information for the system inventory and configuration management.

  • Reviewing audit reports, responding to findings, and taking appropriate actions to ensure GxP compliance in collaboration with Business Technology (BT) and other supporting function as required.

  • Snow Ticket approvals as required.

  • Work with QMS (Quality Management System) Process Owners to identify and execute process simplification using system capabilities.

  • Represents the business in the EtQ Value Team (VT)

  • Participate in projects (DataMart, PowerBI, ServiceNow) to provide input.

Note: Activities are in support of internal or external firms generating GMP (Good Manufacturing Practices) or GDP (Good Documentation Practice) data.

Required Education, Experience, and Skills   

  • BS degree in life science (e.g., Microbiology, Chemistry, Biochemistry), IT or engineering discipline.

  • Applied professional work experience in pharmaceutical quality, laboratory, or manufacturing operations.

  • Quality Assurance, Quality Control, IT and/or Computer System Validation (CSV) experience.

  • Strong working knowledge of OMS (Organon Manufacturing & Supply) business processes and the corresponding computerized systems. ORD (Organon Research & Development) experience is a plus.

  • Understanding of Data Integrity regulations and requirements

Preferred:

  • Demonstrated management/leadership skills.

  • Strong skills at team facilitation, team organization and listening.

  • Strong collaborative and communication skills to manage teams including ability to communicate effectively in multiple directions.

  • Track record of successful Program/ project management skills.

  • Strong in-depth understanding of Health Authorities regulatory requirements and compliance/quality requirements, especially as it pertains to data integrity.

  • Comprehensive understanding of Quality activities and functions

  • Extensive experience in supporting regulatory inspections and/or performing audits.

  • Experience executing Quality Risk Management Tools and principles.

  • Experience development and deploying effective system trainings.

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 Womenâs 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. 

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.

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

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

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R525025