Associate Director Quality Management Systems, EtQ Business Owner

6 days ago


Cramlington, Northumberland, United Kingdom Organon Full time

Job Description

We are currently looking for an EtQ Business Owner to join our team. As the EtQ Business Owner, you will play a crucial role in ensuring the availability, support, and maintenance of EtQ while maintaining the security of the data within the system.

In this position, you will be responsible for ensuring that the EtQ application complies with the associated GMP/GDP process Standard Operating Procedures (SOPs) and is suitable for its intended use.

You will collaborate with Global Process Owners, Site Process Subject Matter Experts (SMEs), and users to advocate for their requirements.

Responsibilities

  • Support the development and implementation of the EtQ Roadmap.
  • Define Requirements, Scope, and Priorities for enhancements.
  • Engage with vendors to represent the voice of the customer.
  • Lead Computer System Validation (CSV) activities for the platform and modules in coordination with Process Owners.
  • Establish procedures for System usage and maintaining a validated state, ensuring adherence to SOPs for system maintenance.
  • Identify and Mitigate Compliance Risks within the EtQ system utilizing Failure Mode Effects Analysis (FMEA).
  • Monitor trends in platform/module incidents and issues.
  • Manage Deviations and Corrective/Preventive Actions (CAPAs) for the EtQ system.
  • Conduct Periodic Reviews and User Access Reviews for the system.
  • Manage system changes effectively.
  • Ensure the availability of information for system inventory and configuration management.
  • Review audit reports, address findings, and take necessary actions to ensure GxP compliance in collaboration with Business Technology (BT) and other supporting functions.
  • Handle Snow Ticket approvals as necessary.
  • Collaborate with Quality Management System (QMS) Process Owners to simplify processes using system capabilities.
  • Represent the business in the EtQ Value Team (VT).
  • Participate in projects such as DataMart, PowerBI, and ServiceNow to provide insights.

Note: These activities support firms, both internal and external, in generating data compliant with GMP (Good Manufacturing Practices) or GDP (Good Documentation Practice) standards.

Required Education, Experience, and Skills

  • Holds a degree in life sciences (e.g., Microbiology, Chemistry, Biochemistry), IT, or engineering.
  • Possesses practical work experience in pharmaceutical quality, laboratory, or manufacturing operations.
  • Experience in Quality Assurance, Quality Control, IT, and/or Computer System Validation (CSV).
  • Solid understanding of OMS (Organon Manufacturing & Supply) business processes and associated computerized systems.
  • Familiarity with Data Integrity regulations and requirements.

Preferred Experience

  • Demonstrated management and leadership abilities.
  • Proficient in team facilitation, organization, and listening skills.
  • Strong collaboration and communication skills for effective team management.
  • Proven track record in Program/Project management.
  • In-depth knowledge of Health Authorities' regulatory requirements and quality/compliance standards regarding data integrity.
  • Comprehensive understanding of Quality operations and functions.
  • Extensive experience in supporting regulatory inspections and conducting audits.
  • Familiarity with Quality Risk Management Tools and principles.
  • Experience in developing and delivering system trainings effectively.

Who We Are

Organon is dedicated to providing innovative healthcare solutions that empower individuals to lead healthier lives. As a leading global healthcare company with a focus on Women's Health, we are committed to addressing unmet needs, expanding access to biosimilars, and enriching lives with a diverse portfolio of health solutions. Our goal is to improve the well-being of women every day.

As an equal opportunity employer, we encourage applications from candidates with diverse backgrounds and are dedicated to fostering an inclusive environment for all applicants.

General Information

Annualized Salary Range

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: Not specified

Travel Requirements: Organon employees must meet all travel and credentialing prerequisites, including relevant vaccination requirements.

Flexible Work Arrangements: Remote Work

Number of Openings: 1



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