Change Control Manager Vila Nova de Gaia

Change Control Manager
Vila Nova de Gaia
Vila Nova de Gaia, Porto District, Portugal

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Client:

Avantor

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

e01acf07c598

Job Views:

5

Posted:

17. 08. 2025

Expiry Date:

01. 10. 2025

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Job Description:

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
- conformances, failure investigation reports and corrective/preventive actions; develop strategies for continuous improvement

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
- conformances, failure investigation reports and corrective/preventive actions; develop strategies for continuous improvement

WHAT WE'RE LOOKING FOR:

The Quality Change Control Manager plays a key role in supporting and overseeing the organization’s 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,
- assessed, implemented, and tracked in compliance with regulatory standards and internal quality expectations.

Acting as a
- 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
- wide. The manager also leads the resolution of escalations and oversees
- impact changes to ensure effective handling and timely closure in line with Avantor’s operational requirements. Monitoring timelines, due dates, and compliance milestones is key to delivering a responsive and resilient change control environment.

CERTIFICATIONS:

Bachelor’s or Master’s 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
- functional teams and influence across levels

Excellent communication, analytical, and
- 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
- 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
- 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
- in from senior leadership.

Proficiency in Microsoft Outlook, Word, Excel, Power
Point, 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
- 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
- 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
- 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 14, 000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances
- changing science.

The work we do changes people's 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 mom's 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
- tax pay for this position is

€72. 000, 00 - €120. 000, 00

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 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.

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