Change Manager

Extremity Care - Conshohocken, PA

Full-time - Mid Level

Conshohocken, PA

Miscellaneous Manufacturing

About the position

The Change Manager is a pivotal role within the Extremity Care division, responsible for overseeing the change control program, document control program, record management, and training program to ensure compliance with regulatory requirements. This position requires a comprehensive understanding of FDA regulations and the ability to implement and manage processes that align with these standards. The Change Manager will work closely with various stakeholders to facilitate smooth transitions and ensure that all documentation is accurate, consistent, and compliant with established formatting and template requirements. In this role, the Change Manager will manage the change control program, which includes overseeing the document change order system and workflow. They will provide technical writing support and review for document change orders, ensuring that all changes are well-documented and communicated effectively. The Change Manager will also collaborate with end users to identify solutions that facilitate operational tasks, thereby enhancing efficiency and productivity within the organization. Additionally, the Change Manager will be responsible for revising and finalizing controlled documents, authoring and revising procedures in accordance with FDA, AATB, and other relevant regulations. They will manage the periodic review of controlled documents and coordinate training requirements for new and existing employees. This includes serving as the administrator for the electronic Quality Management System (eQMS), managing record storage and archival processes, and providing quarterly and annual data analytics and reporting for quality events. The Change Manager will also initiate, review, and investigate quality events, determining appropriate containment and preventive/corrective actions. They will support and perform internal and external audits, develop strategies for adopting changes, and ensure that project timelines and objectives are met. A strong working knowledge of regulatory requirements is essential for success in this role, along with the ability to perform other related duties as assigned.

Responsibilities

• Manage change control program.
• Manage document change order system and workflow.
• Provide technical writing support and review for document change orders.
• Provide guidance for stakeholders during document collaboration to ensure lean implementation of processes and documentation.
• Collaborate with end users to determine solutions for operational tasks.
• Provide effective communication to various teams to execute successful transitions.
• Support continuous process improvements.
• Revise and finalize controlled documents, ensuring consistency and compliance to formatting/template requirements.
• Author/revise procedures according to FDA, AATB, and other regulations.
• Manage and coordinate periodic review of controlled documents.
• Manage and coordinate new employee onboarding training requirements/assignments.
• Manage and coordinate recurring employee training requirements/assignments.
• Serve as administrator for eQMS for user addition, role configuration, and other functions.
• Manage record storage and archival in accordance with standard operating procedures.
• Manage SOP table of contents, master label list, equipment list, signature log, training matrix, and quality event log.
• Provide quarterly and annual data analytics and reporting for quality events.
• Initiate, review, and investigate quality events and determine appropriate actions.
• Support and/or perform internal and external audits.
• Develop and implement strategies for adopting changes and ensuring project objectives are met.
• Maintain working knowledge of regulatory requirements.

Requirements

• Bachelor's degree (life science and/or technical writing preferred).
• At least 5 years of quality experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field) required.
• Strong management and leadership skills.
• Excellent attention to detail.
• Strong public speaking skills.
• Technical writing skills.
• Strong analytical thinking.
• Ability to multi-task and work in a fast-paced environment.
• Effective verbal and written communication skills.
• Proficient in Microsoft Office.