Avantor Sciences is looking for a Change Control Manager to play a key role in overseeing and harmonizing change control processes across our global Quality Management System (QMS). In this role, you will coordinate implementation across multiple sites to ensure consistent quality standards and regulatory compliance enterprise-wide.

What You'll Do

Lead the implementation and optimization of change control processes to ensure consistent compliance with regulatory standards and internal quality policies.
Coordinate and oversee risk assessments and change evaluations, ensuring thorough documentation and effective execution.
Monitor and enforce adherence to applicable regulations, standards, and company procedures.
Provide training and mentorship to personnel, promoting best practices in change control across the organization.
Contribute strategic input to Quality Management System (QMS) enhancements and continuous improvement efforts.
Develop and present performance metrics and audit-ready reports to senior management.
Act as a subject matter expert during inspections and customer audits, representing the change control process.
Support and guide local change management teams, fostering professional growth and cross-site collaboration.
Manage critical and escalated changes, ensuring timely resolution and minimal operational disruption.
Support complex projects with significant business impact, coordinating meetings, creating action plans, and leading initiatives to project close.
Facilitate and support software-related changes within QMS platforms, ensuring effective integration and functionality.
Maintain productive relationships with internal and external stakeholders to enable successful change execution.
Remain current with evolving regulatory requirements and quality standards, ensuring proactive adaptation within change management practices.

What We're Looking For

Bachelor’s or Master’s degree in Life Sciences, Engineering, or a Quality-related field.
5+ years of experience in a regulated industry with leadership experience in change control or quality management – preferably in chemical manufacturing or bioprocessing.
Deep understanding of ICH, FDA, EMA, and ISO requirements.
Proven ability to lead cross-functional teams and influence across levels.
Proficiency in QMS software and data analytics.
Working knowledge of GMP, quality operations, and change control.
Able to assess change impact by conducting impact analyses, assess change readiness, and identify key stakeholders.
Excellent communication, leadership, analytical, and decision-making skills.
Ability to work independently and as part of a team, managing multiple projects simultaneously to meet deadlines.
Knowledge of ISO9001, ISO13485, ICH Q7, Data Integrity framework, and FDA regulations.
Ability to work in a fast-paced environment to meet internal demands under tight timelines.
Strong interpersonal and people management skills to guide critical decision alignment supporting a global process and system.

Nice to Have

Ability to interact with and gain buy-in from senior leadership.
Proficiency in Microsoft Outlook, Word, Excel, PowerPoint, Visio, Teams, and chromatography/LIMS software.
SAP experience is an asset.
Strong time management and prioritization skills.
Ability to liaise with different departments to ensure software compliance with regulatory requirements.
Self-motivated to drive global lab modernization projects and improvements.

Technical Stack

QMS software
Data analytics tools
Microsoft Outlook, Word, Excel, PowerPoint, Visio, Teams
Chromatography/LIMS software
SAP

Team & Environment

Acting as a cross-functional liaison, the manager fosters collaboration across departments.

Benefits & Compensation

Compensation range: €72.000,00 - €120.000,00
Diverse, equitable, and inclusive culture which includes learning experiences to support your career growth and success.