Change Control Manager

Description:

The Change Control Manager leads and manages the quality organization’s change control processes within the Quality Management System (QMS) at Avantor’s facility. This role ensures that all changes to systems, processes, equipment, materials, and documentation comply with regulatory requirements and internal quality standards. The manager acts as a cross-functional liaison, driving collaboration and continuous improvement across multiple global sites.

Key Responsibilities:

• Manage and oversee change control activities ensuring compliance with FDA CFRs, ICH, EMA, ISO standards, and internal policies.

• Develop and maintain quality management systems aligned with regulatory requirements.

• Monitor and ensure timely closure of non-conformances, failure investigations, and corrective/preventive actions.

• Lead risk assessments, change evaluations, and documentation.

• Coordinate change control implementation across global sites to harmonize processes.

• Manage escalations and high-impact changes to ensure timely resolution.

• Provide training, mentorship, and guidance on best practices.

• Prepare and present performance metrics and audit-ready reports.

• Support software-related QMS changes and lab modernization projects.

• Serve as subject matter expert during inspections and audits.

• Maintain relationships with internal and external stakeholders.

• Stay current on evolving regulatory and quality standards.

Required Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or related Quality field.

• 5+ years of leadership experience in change control or quality management within regulated industries (chemical manufacturing or bioprocessing preferred).

• Deep knowledge of ICH, FDA, EMA, ISO9001, ISO13485, ICH Q7, Data Integrity, GMP, and regulatory compliance.

• Proven ability to lead cross-functional teams and influence senior leadership.

• Strong communication, analytical, decision-making, and project management skills.

• Proficiency with QMS software, data analytics, Microsoft Office suite; SAP and chromatography/LIMS software experience is an asset.

• Ability to work independently and manage multiple projects under tight deadlines.

Preferred Qualifications:

• Experience with global process harmonization and large-scale implementations.

• Ability to liaise effectively with various departments.

• Self-motivated to drive global lab modernization and continuous improvements.