What are the responsibilities and job description for the Change Control Manager position at Anovorx Group LLC?
Job Summary:
Reporting to the Sr. Manager of Quality, the Change Control Manager will oversee and administer changes to company policies, standard operating procedures (SOPs), job aids, and other controlled documents, as well as manage change requests related to technology, facilities, and operations. They will work closely with cross-functional teams to review policy documentation, evaluate, coordinate, and document change requests, ensuring consistency, accuracy, and compliance across all controlled systems and processes. The below is intended to describe the general content of and requirements for the performance of this job and is not to be construed as an exhaustive statement of essential functions, responsibilities, or requirements.
Primary Duties and Responsibilities
Change Control Management
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Administer and manage the lifecycle of change requests for:
- Documentation: Policies, procedures, job aids, and training materials.
- Technology: Software upgrades, system implementations, and IT infrastructure changes.
- Facilities: Physical modifications, equipment changes, and operational updates.
- Coordinate cross-functional reviews and approvals to evaluate the scope, impact, and timelines of proposed changes.
- Maintain detailed records of all change requests, assessments, approvals, and implementations in the QMS.
- Conduct impact assessments to ensure compliance with ISO 9001:2015 and other applicable standards.
- Lead change control meetings to review and prioritize requests, ensuring alignment across departments.
- Monitor implementation timelines and follow up on change completion to ensure successful integration.
Audit and Compliance Support
- Prepare for internal and external audits by ensuring all controlled documents and changes are accurately documented and accessible.
- Address audit findings related to documentation or change control and implement corrective actions to resolve gaps.
Training and Communication
- Communicate updates to policies, procedures, and operational changes across the organization.
- Develop and deliver training materials and job aids to support the adoption of changes.
- Serve as a resource to employees for understanding change control processes and regulatory compliance requirements.
Process Improvement
- Continuously evaluate and enhance change control and documentation processes to improve efficiency and maintain compliance.
- Identify opportunities to streamline workflows and improve system integrations for better change management outcomes.
Policy Writing and Documentation
- Develop, review, and maintain company policies, SOPs, job aids, and other controlled documents to align with regulatory and quality standards.
- Collaborate with subject matter experts (SMEs) to gather information, ensuring technical accuracy and clarity in documentation.
- Standardize formats and templates for all documentation to ensure a consistent and professional presentation.
- Facilitate the approval process for newly created or revised documents and manage their distribution to relevant stakeholders.
- Regular and reliable attendance expected.
- Other work-related duties as assigned by supervisor/manager.
Minimum Knowledge, Abilities, and Skills Required
- Bachelor’s degree in Quality Management, Regulatory Affairs, Technical Writing, Health Administration, or a related field.
- At least five (5) years of experience in policy writing, document control, or change management in a regulated industry.
- At least three (3) years in supervisory/managerial capacity.
- Experience managing technology and facility changes within a QMS framework is highly desirable.
- Proficiency in QMS software, document management tools, and Microsoft Office Suite.
- Familiarity with IT change management tools or facility project management systems is a plus.
- In-depth knowledge of ISO 9001:2015 standards, quality management principles, and change control methodologies.
- Strong writing, editing, and communication skills.
- Excellent project management and organizational abilities.
- Ability to work collaboratively with diverse teams and manage multiple priorities in a hybrid working environment.
This description is intended to be only a general outline of major activities. It is expected that the employee performs these and any other activities which may be assigned, or which may occur in the normal course of work. This description is not a contract or guarantee of employment. AnovoRx is an Equal Opportunity Employer.
