Quality Management System (QMS) Change Management Specialist

Quality Management System (QMS) Change Management

Job Summary : We are seeking a highly skilled and experienced Quality Management System (QMS) Change Management Specialist to join our team on a contract basis.

The successful candidate will be responsible for reviewing, updating, and creating QMS Change Management processes.

This role will involve defining and gathering requirements, process updates, and process creation for Technical Operations, Development Operations, Services Validation, Support, and Quality teams within Digital Science Automation Solutions. Experience with AWS Cloud Services is required to ensure seamless integration with our digital infrastructure.

Key Responsibilities :

1.Requirements Definition and Gathering : oCollaborate with stakeholders across Technical Operations, Development Operations, Services Validation, Support, and Quality teams to define and gather detailed requirements for QMS Change Management processes. Conduct interviews, workshops, and surveys to collect input and feedback from various teams.oDocument and prioritize requirements to ensure alignment with organizational objectives and compliance standards

• .2.Process Updates and Creation : Analyze existing QMS Change Management processes to identify areas for improvement and ensure they meet current regulatory and compliance requirements.oDesign, develop, and implement updated and new QMS Change Management processes. Ensure that all process updates and creations are clearly documented, including process maps, standard operating procedures (SOPs), and work instructions.

3.Stakeholder Collaboration : oWork closely with cross-functional teams to ensure seamless integration and alignment of new and updated processes.oFacilitate effective communication and collaboration between stakeholders to ensure successful process adoption and implementation.Provide training and support to stakeholders on new and updated QMS Change Management processes.

4.Compliance and Quality Assurance : Ensure that all QMS Change Management processes comply with relevant industry standards, regulations, and best practices. Conduct regular audits and reviews to ensure ongoing compliance and effectiveness of QMS Change Management processes. Develop and implement metrics to monitor the performance and effectiveness of QMS Change Management processes.

5. AWS Cloud Services Integration : Utilize AWS Cloud Services to enhance and support QMS Change Management processes. Ensure that QMS processes are designed to leverage AWS Cloud Services for scalability, security, and efficiency. Collaborate with IT and cloud infrastructure teams to ensure seamless integration and operation of QMS processes within the AWS environment.

6.Continuous Improvement : Identify opportunities for continuous improvement in QMS Change Management processes. Stay up to date with industry trends, best practices, and regulatory changes to ensure that QMS Change Management processes remain current and effective. Lead and participate in continuous improvement initiatives to enhance the overall quality and efficiency of QMS Change Management processes.

Qualifications :  5 + years of experience in Quality Management Systems and Change Management, preferably within the digital science automation or related industry.

Strong knowledge of industry standards and regulations related to Quality Management Systems (e.g., ISO 9001, ISO 13485, FDA regulations).Proven experience in process analysis, design, and implementation.

Hands-on experience with AWS Cloud Services, including but not limited to EC2, S3, RDS, Lambda, and CloudFormation . Excellent communication, collaboration, and stakeholder management skills.

Strong analytical and problem-solving abilities.

Proficiency in using QMS software and tools.

Certification in Quality Management (e.g., Six Sigma, Lean, ASQ) is a plus.

Skills Required

S3, Rds, Lambda