Quality Assurance Officer ATMP (maternity replacement)

Evotec WD; Modena; On-site; EUR 45,000 - 65,000; Full time

Job summary

Evotec is seeking a GMP Quality Assurance professional for its cell therapy manufacturing site in Modena, Italy. The role focuses on ensuring ATMP manufacturing compliance, managing documentation, and driving improvements across the Cell Factory operations.

The ideal candidate has at least 3 years in QA, knowledge of GxP, and experience with sterile products and environmental monitoring. Proactive, team-focused individuals with strong organizational skills are encouraged to apply.

Qualifications

• Minimum 3 years of Quality Assurance experience.
• ATMP experience is a plus.
• Experience with sterile products is desirable.
• Experience in environmental monitoring and safety methods is preferred.
• Documentation management of GMP records is required.

Responsibilities

• Manage a comprehensive QA documentation system for Cell Factory operations.
• Collaborate in risk analyses to ensure product quality and compliance.
• Contribute to change management processes.
• Oversee deviations and CAPA activities and track closeout.
• Regularly inspect all departments for GMP compliance and readiness.
• Contribute to training plans for new and existing staff.
• Qualify external suppliers and monitor performance.
• Handle complaints and ensure timely resolution.
• Distribute production batch records and ensure accuracy.
• Execute Batch Record Review and ensure traceability.

Skills

GxP knowledge

Teamwork

Prioritization

Deadline driven

English (intermediate)

MS Office

Education

BS/MS in Biotechnology/Biology/Pharmacy

Job description

Evotec is a leader in the discovery and development of novel small molecule drugs with operational sites in Europe and the US. The Company has built substantial drug discovery and development expertise and an industrialized platform that can drive new innovative small molecule compounds into the clinic. In addition, Evotec is building an integrated platform to deliver iPSC-based therapeutics to patients and an innovative off-the-shelf cell therapy project portfolio. Leveraging these skills and expertise the Company intends to develop best-in-class differentiated therapeutics and deliver superior science-driven discovery and development alliances with pharmaceutical and biotechnology companies.For our cell therapy manufacturing site in Modena, we are looking for a highly motivated GMP Quality Assurance, possibly experienced in aseptic manufacturing. This position will have a key role in Cell and Gene therapy team to guarantee company and intercompany ATMP manufacturing activities .Essential Functionsmanage a comprehensive documentation system for all Cell Factory operationscollaborating in risk analysiscollaborating in change management systemmanaging deviations and corrective/preventive actionsregularly inspect all departments and assess their GMP compliance statussupport the development of appropriate training plans for new and existing staffqualify external suppliershandling complaintsdistributing production batch recordsexecute the Batch Record ReviewDocument managementRequired Skills & AbilitiesKnowledge of current GxP guidelinesPositive, team player and problem-solving attitudeAccurate, with excellent prioritization and organization skillsCommitment to the assigned deadlines and ability to deliver them tightlyEnglish intermediate level is required (written and spoken)Good knowledge of Microsoft Office applicationsEducationBS or MS Scientific Degree (e.g. Biotechnology, Biology, Pharmacy, CTF…)ExperiencePrevious experience in Quality Assurance is mandatory (3+ years)Previous experience with ATMPs is a plusPrevious experience with sterile productsPrevious experience in environmental monitoring, safety methods and mediafill activitiesFR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.EN: In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.IT: In compliance with fundamental ethical and professional principles and with Legislative Decree 198/2006, Evotec is an Equal Opportunity Employer committed to fostering a safe, diverse, and inclusive workplace built on mutual respect. We provide equal employment opportunities to all qualified candidates and employees based on their skills, experience, and professional qualifications. In line with our ethical and professional principles, all employment-related decisions, including recruitment and selection processes, are made fairly and without any form of discrimination. All qualified candidates will be considered for employment regardless of race, color, sex, age, disability, genetic information, gender expression, gender identity, nationality, religion, sexual orientation, or any other characteristic protected under applicable law.