CQV compliance Specialist - CDD

Evotec WD; Toulouse; Sur place; EUR 55 000 - 85 000; Plein temps

Résumé du poste

Evotec in Toulouse is looking for a CQV Compliance Specialist (F/M/D) to support MSAT quality systems and regulatory alignment in a cGMP environment. The role focuses on documentation, deviations, CAPAs, and change controls.

You will partner with MSAT, Quality, and Manufacturing across sites, coordinate document lifecycles, perform investigations with root cause analysis, and drive continuous improvement in compliance processes.

Qualifications

• Bachelor's degree in a scientific, engineering, or technical field.
• 4–5 years of experience in a cGMP-regulated manufacturing environment.
• Fluent in French and English with strong communication.

Responsabilités

• Coordinate quality and compliance documentation for MSAT teams.
• Lead investigations and CAPA follow-up with root cause analysis.
• Manage deviations, change controls, and related action plans.
• Monitor compliance trends and support data-driven decisions.
• Collaborate with Quality, Manufacturing, and MSAT teams.

Connaissances

French (Fluent)

English (Fluent)

Root cause investigations

FMEA

cGMP knowledge

Quality systems

Documentation management

Formation

Bachelor's degree in science/engineering

Description du poste

Job Title: CQV Compliance Specialist (F/M/D) Type de contrat: CDD Lieu : Toulouse Département : MSAT/CQV We're excited to share this opportunity is part of the Sandoz acquisition of Just-Evotec Biologics in Toulouse. Through this opportunity you will impact the lives of hundreds of millions of people through bold ideas supported by an inclusive, agile company culture. Join us to help make healthcare fairer and faster, help us to pioneer access to medicine!

What You'll Do:

The MSAT Compliance Specialist plays a key role in supporting compliance activities across MSAT, ensuring documentation, quality systems, and action plans are effectively managed and aligned with internal procedures and regulatory requirements.

Missions:

• Coordinate and provide the required quality and compliance documentation to MSAT teams, ensuring timely access to relevant information and records;
• Act as a key partner for MSAT stakeholders in the management and follow-up of deviations, CAPAs, change controls, and related action plans;
• Lead and support investigations related to deviations, ensuring thorough root cause analysis and timely implementation of corrective and preventive actions;
• Monitor compliance trends and perform data analysis to identify improvement opportunities and support proactive decision-making;
• Coordinate and manage document lifecycle activities, including SOP updates, document revisions, and change implementation;
• Ensure the effective tracking, execution, and closure of quality records and compliance actions, fostering continuous improvement and operational excellence;
• Collaborate cross-functionally with Quality, Manufacturing, and MSAT teams to promote compliance, strengthen processes, and support business objectives.

Who You Are:

• Bachelor's degree in a scientific, engineering, or technical field, with 4-5 years of experience in a cGMP-regulated manufacturing environment.
• Fluent in French and English, with strong communication and stakeholder management skills.
• Experienced in root cause investigations (5 Whys, Ishikawa, etc.) and risk management methodologies such as FMEA.
• Solid understanding of cGMP requirements and quality systems, including deviations, CAPAs, and change controls.
• Detail-oriented, proactive, and solution-driven, with a strong commitment to quality and continuous improvement.
• Collaborative team player, able to work effectively across functions and manage multiple priorities.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape!

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

Just Evotec Biologics, wholly owned by Evotec SE, is a first-to-industry biologics platform that leverages AI/ML technologies and world-leading molecular design, cell line development, process intensification and continuous manufacturing strategies to advance biotherapeutics from discovery through clinical stages to commercial launch. The Just Evotec Biologics team combines deep industry experience in the fields of data, protein, process, and manufacturing sciences including automation with highly integrated and flexible capabilities to break through the scientific and economic barriers associated with the development of protein therapeutics. Our focus is to accelerate and expand access to biotherapeutics through scientific and technological innovation for our proprietary projects and on behalf of our partners. Learn more at www.just-evotecbiologics.com.