Current jobs related to Associate Director Quality Management Systems, EtQ Business Owner - Cramlington, Northumberland - Organon

  • Associate Director of Global Product Management

    2 weeks ago

    Cramlington, Northumberland, United Kingdom Organon Full time

    **Job Summary**We are seeking an experienced Associate Director to lead our Value Chain Management team in driving business growth and excellence. As a key member of our organization, you will be responsible for developing and implementing strategic plans to optimize our product portfolio and supply chain.Key Responsibilities:Develop and execute...

  • Quality Assurance Specialist

    5 hours ago

    Cramlington, Northumberland, United Kingdom Enerpac Tool Group Full time

    About the RoleWe are seeking a highly skilled Quality Inspector to join our team at Enerpac Tool Group. As a Quality Inspector, you will play a critical role in ensuring the quality and traceability of all manufactured components in accordance with our Management System.Key Responsibilities• Perform inspection requirements in accordance with our Product...

  • Quality Assurance Specialist

    2 hours ago

    Cramlington, Northumberland, United Kingdom Enerpac Tool Group Full time

    About the RoleWe are seeking a highly skilled Quality Inspector to join our team at Enerpac Tool Group. As a Quality Inspector, you will play a critical role in ensuring the quality and traceability of all manufactured components in accordance with our Management System.Key Responsibilities• Perform inspection requirements in accordance with our Product...

  • Quality Assurance Specialist

    2 weeks ago

    Cramlington, Northumberland, United Kingdom Enerpac Tool Group Full time

    About Enerpac Tool GroupEnerpac Tool Group is a leading manufacturer of high-pressure hydraulic tools and equipment. We are committed to delivering innovative solutions that meet the needs of our customers.Job SummaryWe are seeking a Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality and...

  • Quality Assurance Specialist

    2 weeks ago

    Cramlington, Northumberland, United Kingdom Enerpac Tool Group Full time

    About Enerpac Tool GroupEnerpac Tool Group is a leading manufacturer of high-pressure hydraulic tools and equipment. We are committed to delivering innovative solutions that meet the needs of our customers.Job SummaryWe are seeking a Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality and...

  • Quality Assurance Manager

    1 month ago

    Cramlington, Northumberland, United Kingdom MTrec Ltd Full time

    Job Overview MTrec Ltd is seeking a dedicated Quality Assurance Manager to join our esteemed precision engineering team. This role is pivotal in ensuring that our products consistently meet the highest standards of quality. Working Hours This position operates on a day shift schedule: Monday to Wednesday: 7am to 5pm Thursday: 7am to 3pm Benefits Company...

  • Pharmaceutical Quality Assurance Specialist

    2 weeks ago

    Cramlington, Northumberland, United Kingdom Central Employment Agency (North East) Limited Full time

    Central Employment Agency (North East) Limited is pleased to present an exciting opportunity to work in a global pharmaceutical business. The role will be part of the Quality Assurance team, responsible for creating, monitoring, and implementing quality systems that meet the requirements of a pharmaceutical manufacturer. This is an excellent opportunity to...

  • Pharmaceutical Quality Assurance Specialist

    2 weeks ago

    Cramlington, Northumberland, United Kingdom Central Employment Agency (North East) Limited Full time

    Central Employment Agency (North East) Limited is pleased to present an exciting opportunity to work in a global pharmaceutical business. The role will be part of the Quality Assurance team, responsible for creating, monitoring, and implementing quality systems that meet the requirements of a pharmaceutical manufacturer. This is an excellent opportunity to...

  • Pharmaceutical Quality Assurance Specialist

    2 weeks ago

    Cramlington, Northumberland, United Kingdom Central Employment Agency Full time

    Central Employment Agency is proud to present a graduate opportunity working in a global pharmaceutical business. The opportunity will be working in the Quality Assurance team creating, monitoring and implementing Quality systems that are required in a pharmaceutical manufacturer. This is an excellent opportunity to join a leading business, understanding the...

  • Pharmaceutical Quality Assurance Specialist

    2 weeks ago

    Cramlington, Northumberland, United Kingdom Central Employment Agency Full time

    Central Employment Agency is proud to present a graduate opportunity working in a global pharmaceutical business. The opportunity will be working in the Quality Assurance team creating, monitoring and implementing Quality systems that are required in a pharmaceutical manufacturer. This is an excellent opportunity to join a leading business, understanding the...

  • Contract Quality Assurance Specialist

    23 hours ago

    Cramlington, Northumberland, United Kingdom Central Employment Agency Full time

    Quality Assurance Graduate OpportunityCentral Employment Agency is excited to present a graduate opportunity in a global pharmaceutical business. This role will be working in the Quality Assurance team, creating, monitoring, and implementing Quality systems that meet regulatory requirements.Key Responsibilities:Provide Quality support for regulatory, global...

  • Contract Quality Assurance Specialist

    1 day ago

    Cramlington, Northumberland, United Kingdom Central Employment Agency Full time

    Quality Assurance Graduate OpportunityCentral Employment Agency is excited to present a graduate opportunity in a global pharmaceutical business. This role will be working in the Quality Assurance team, creating, monitoring, and implementing Quality systems that meet regulatory requirements.Key Responsibilities:Provide Quality support for regulatory, global...

  • Pharmaceutical Quality Control Professional

    2 weeks ago

    Cramlington, Northumberland, United Kingdom Central Employment Agency (North East) Limited Full time

    **Job Title:** QA Analyst**Job Summary:** Central Employment Agency (North East) Limited is seeking a highly skilled QA Analyst to join our team. As a QA Analyst, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.**Key Responsibilities:****Provide Quality Support:** Offer quality support for regulatory,...

  • Commercial Director Service

    2 days ago

    Cramlington, Northumberland, United Kingdom Enerpac Tool Group Full time

    OverviewEnerpac Tool Group is seeking a seasoned Commercial Director to lead our Service business in EMEA. As a key member of our leadership team, you will be responsible for driving revenue growth, expanding market share, and delivering exceptional customer experiences.Key Responsibilities:Develop and execute the regional service strategy to achieve sales...

  • Commercial Director Service

    2 days ago

    Cramlington, Northumberland, United Kingdom Enerpac Tool Group Full time

    OverviewEnerpac Tool Group is seeking a seasoned Commercial Director to lead our Service business in EMEA. As a key member of our leadership team, you will be responsible for driving revenue growth, expanding market share, and delivering exceptional customer experiences.Key Responsibilities:Develop and execute the regional service strategy to achieve sales...

  • Electrical Systems Manager

    3 days ago

    Cramlington, Northumberland, United Kingdom Organon Full time

    Electrical Lead Job DescriptionOrganon is seeking an Electrical Lead to join our manufacturing site in Cramlington, Northumberland. In this role, you will be responsible for providing system ownership and guidance of all Electrical systems, including technical support in the development of Electrical maintenance strategies, modifications, continuous...

  • Electrical Systems Manager

    3 days ago

    Cramlington, Northumberland, United Kingdom Organon Full time

    Electrical Lead Job DescriptionOrganon is seeking an Electrical Lead to join our manufacturing site in Cramlington, Northumberland. In this role, you will be responsible for providing system ownership and guidance of all Electrical systems, including technical support in the development of Electrical maintenance strategies, modifications, continuous...

  • Commercial Director Service

    3 days ago

    Cramlington, Northumberland, United Kingdom Enerpac Tool Group Full time

    OverviewEnerpac Tool Group is seeking a seasoned Commercial Director to lead our Service business in EMEA. As a key member of our leadership team, you will be responsible for driving revenue growth, expanding market share, and delivering exceptional customer experiences.Key Responsibilities:Develop and execute the regional service strategy to achieve sales...

  • Commercial Director Service

    3 days ago

    Cramlington, Northumberland, United Kingdom Enerpac Tool Group Full time

    OverviewEnerpac Tool Group is seeking a seasoned Commercial Director to lead our Service business in EMEA. As a key member of our leadership team, you will be responsible for driving revenue growth, expanding market share, and delivering exceptional customer experiences.Key Responsibilities:Develop and execute the regional service strategy to achieve sales...

  • Electrical Systems Manager

    1 week ago

    Cramlington, Northumberland, United Kingdom Organon Full time

    {"Role Overview": "As an Electrical Lead at Organon, you will be responsible for providing system ownership and guidance of all Electrical systems. This includes technical support in the development of all Electrical maintenance strategies, modifications, continuous improvements, capital projects, and energy reduction initiatives.", "Key Responsibilities":...

Associate Director Quality Management Systems, EtQ Business Owner

4 months ago

Cramlington, Northumberland, 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 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.

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

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