Merck Gruppe - MSD Sharp & Dohme
Associate Director, Quality Assurance - Change Control
Merck Gruppe - MSD Sharp & Dohme, Rahway, New Jersey, us, 07065
Job DescriptionPosition DescriptionAssociate Director, Quality Management System Change Control will work with the Change Control core team, Sites, Functional Groups and Additional Stakeholders to sustain and continuously improve the Change Control QMS (People, Process, System). The person in this position has experience in good manufacturing practices within the pharmaceutical industry, including change control experience. They will provide support to the change control quality system codified in our Company Quality Manual, monitor the performance of the quality system, and drive continuous improvement efforts. This role involves monitoring site adherence to the company’s change control quality system, championing standard work across all sites, and assisting sites in troubleshooting change control issues. Additionally, the person will lead a Community of Practice, develop and maintain global training materials, and serve as a subject matter expert on information systems supporting change control.Primary activities include, but are not limited to:Monitor health authority regulations and ensure that relevant regulations are incorporated into the change control Quality Management System documents.
Author and maintain global change control topic documents.
Ensure procedures are aligned with other Quality Management System topics and functionality updates to the IT platforms supporting the change control process.
Support development and deployment of new and/or enhancement of existing Change Management processes and systems.
Interact with Batch Disposition personnel, clinical, Integrated Product Data team, and Regulatory scientists to drive further integration of these processes with change control.
Develop and maintain global training materials and deliver training to our Manufacturing Division personnel as needed.
Lead a community of practice for Change Control and manage the content of information placed on the CoP’s website.
Network with functional groups performing change control to provide subject matter expertise, direction, and implement best practices and standards.
Troubleshoot network change control issues and provide guidance on resolution.
Interface with Information Technology group to identify system improvements that enhance the efficiency and effectiveness of the change control process.
Travel 20% of the time to support the change control process at our Manufacturing Division global site network.
This position represents an exciting opportunity for a strong leader to make meaningful contributions to the sustainment of a more efficient and effective change control process. A robust and sustainable change management process is critical to ensure compliance with regulatory dossiers and compliant supply. The selected candidate will work with stakeholders across the globe and become an integral part of our Manufacturing Division journey.Education Minimum Requirement:Bachelor's degree in Science or Engineering; Master’s degree or MBA preferred.
Required Experience and Skills:B.Sc. in a relevant field of science or engineering and a minimum of 5 years in pharmaceutical and/or vaccine manufacturing environment.
Experience with Change Control and the IT systems enabling change control (e.g., Veeva, IPI, Trackwise).
A continuous improvement mindset and bias to action are important for this role.
Preferred Experience and Skills:Background in US and international GMP policy and regulations.
Demonstrated personnel management/leadership skills.
Demonstrated project management/leadership skills.
Strong communication skills.
Working knowledge in Quality Risk Management tools and principles.
Working knowledge of SAP or other relevant ERP system(s).
Employee Status:
RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: 25%Flexible Work Arrangements: HybridJob Posting End Date: 11/1/2024Requisition ID: R316983
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Author and maintain global change control topic documents.
Ensure procedures are aligned with other Quality Management System topics and functionality updates to the IT platforms supporting the change control process.
Support development and deployment of new and/or enhancement of existing Change Management processes and systems.
Interact with Batch Disposition personnel, clinical, Integrated Product Data team, and Regulatory scientists to drive further integration of these processes with change control.
Develop and maintain global training materials and deliver training to our Manufacturing Division personnel as needed.
Lead a community of practice for Change Control and manage the content of information placed on the CoP’s website.
Network with functional groups performing change control to provide subject matter expertise, direction, and implement best practices and standards.
Troubleshoot network change control issues and provide guidance on resolution.
Interface with Information Technology group to identify system improvements that enhance the efficiency and effectiveness of the change control process.
Travel 20% of the time to support the change control process at our Manufacturing Division global site network.
This position represents an exciting opportunity for a strong leader to make meaningful contributions to the sustainment of a more efficient and effective change control process. A robust and sustainable change management process is critical to ensure compliance with regulatory dossiers and compliant supply. The selected candidate will work with stakeholders across the globe and become an integral part of our Manufacturing Division journey.Education Minimum Requirement:Bachelor's degree in Science or Engineering; Master’s degree or MBA preferred.
Required Experience and Skills:B.Sc. in a relevant field of science or engineering and a minimum of 5 years in pharmaceutical and/or vaccine manufacturing environment.
Experience with Change Control and the IT systems enabling change control (e.g., Veeva, IPI, Trackwise).
A continuous improvement mindset and bias to action are important for this role.
Preferred Experience and Skills:Background in US and international GMP policy and regulations.
Demonstrated personnel management/leadership skills.
Demonstrated project management/leadership skills.
Strong communication skills.
Working knowledge in Quality Risk Management tools and principles.
Working knowledge of SAP or other relevant ERP system(s).
Employee Status:
RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: 25%Flexible Work Arrangements: HybridJob Posting End Date: 11/1/2024Requisition ID: R316983
#J-18808-Ljbffr