Change Control Manager

The Opportunity:

Under limited direction direct the activities for the quality organization for their respective facility. Manage organize oversee and ensure the objectives of the QA/QC function are implemented in line with Corporate site quality and business goals. Develop manage and maintain the quality management system to meet applicable regulatory requirements (FDA CFRs U.S and international regulations) and international quality standards; ensure products meet customer quality expectations and requirements. Develop monitor and manage approved departmental budget. Ensure timely closure of all non-conformances failure investigation reports and corrective/preventive actions; develop strategies for continuous improvement

WHAT WERE LOOKING FOR:

The Quality Change Control Manager plays a key role in supporting and overseeing the organizations change control processes within the Quality Management System (QMS) ensuring that proposed changes to systems processes equipment finished goods material and documentation are thoroughly reviewed risk-assessed implemented and tracked in compliance with regulatory standards and internal quality expectations.

Acting as a cross-functional liaison the manager fosters collaboration across departments to promote best practices and continuous improvement. The role includes coordinating change management implementation across multiple global sites ensuring harmonization of processes and consistent quality standards enterprise-wide. The manager also leads the resolution of escalations and oversees high-impact changes to ensure effective handling and timely closure in line with Avantors operational requirements. Monitoring timelines due dates and compliance milestones is key to delivering a responsive and resilient change control environment.

CERTIFICATIONS:

• Bachelors or Masters degree in Life Sciences Engineering or Quality-related field.

EXPERIENCE:

• 5 years of experience in 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
• Excellent communication analytical and decision-making skills
• Proficiency in QMS software and data analytics
• Working knowledge of GMP and regulatory requirements

THOSE NECESSARY TO PERFORM THE JOB COMPETENTLY:

• Must have working knowledge of quality operations and experience with change control
• Able to assess the change impact by conducting impact analyses assess change readiness and identify key stakeholders.
• Excellent communication leadership and interpersonal skills
• Ability to work independently and as part of a team
• Strong attention to detail and problem-solving skills
• Ability to manage multiple projects simultaneously and meet deadlines
• Experience with regulatory compliance and quality control measures
• 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 is a must.
• Ability to lead large scale implementations maintaining timelines.
• Strong interpersonal and people management skills to guide critical decision alignment supporting a global process and system.

PREFERRED QUALIFICATIONS:

• 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.
• Excellent communication skills both written and verbal.
• 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.

HOW YOU WILL THRIVE AND CREATE AN IMPACT:

• 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 (SME) 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/ analysis with significant impact on business. Requiring coordinating and leading meetings initiatives creating and executing action plans 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

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor

Dare to go further in your career. Join our global team of 14000 associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes peoples lives for the better. It brings new patient treatments and therapies to market giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his moms voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

Pay Transparency:

The expected pre-tax pay for this position is

72.00000 - 120.00000

Actual pay may differ depending on relevant factors such as prior experience and geographic location.

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex gender identity sexual orientation race color religious creed national origin physical or mental disability protected Veteran status or any other characteristic protected by federal state/province or local law.

If you need a reasonable accommodation for any part of the employment process please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor or by failing to comply with the Avantor recruitment process you forfeit any fee on the submitted candidates regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.