Manager de Calidad

mAbxience; Madrid; Presencial; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

A leading biopharmaceutical company is seeking a Microbial Control Global Manager in Madrid to develop and implement contamination control strategies. The role involves training staff, ensuring compliance with industry standards, and harmonizing practices across sites, requiring expertise in microbiology and quality assurance.

Formación

• Minimum of 5 years of experience in contamination control, environmental monitoring, or quality assurance.
• Strong knowledge of GMP regulations and industry best practices.
• Experience with risk assessment tools and CAPA processes.

Responsabilidades

• Develop and oversee contamination control strategies in biopharmaceutical manufacturing.
• Ensure compliance with regulatory guidelines and internal quality standards.
• Manage contamination control training programs for staff.

Conocimientos

Problem-solving

Analytical

Communication

Attention to detail

Educación

Bachelor’s or master’s degree in microbiology, Biotechnology, Biochemistry, or a related field

Descripción del empleo

At mAbxience, a company specialized in the development and manufacturing of biosimilar medicines, we are hiring a Microbial Control Global Manager.

General Responsibility

The Microbial Control Global Manager is responsible for developing, implementing, and overseeing contamination control strategies in a biopharmaceutical manufacturing environment across the different sites and proactively ensures compliance with regulatory requirements, industry standards, and company policies to maintain a proactive microbial control strategy to guarantee the safety of the products. This role will serve to execute continuous improvement activities in the microbial area in all sites guaranteeing the harmonization of practices across the different sites. She / he will serve to train and educate in best aseptic practices.

Specific Responsibilities

Continuously improve a comprehensive Contamination Control Strategy (CCS) to minimize microbial, particulate, and chemical contamination risks in.

Harmonize microbial practices across different sites of mAbxience

Provide subject matter expertise during deviation investigations and corrective actions.

Create best practices documents globally to assure harmonization and communication between sites

Communicate proactively improvement opportunities for both sites and make sure implementation and training to the staff

Lead contamination control risk assessments and establish proactive mitigation measures.

Ensure compliance with regulatory guidelines (FDA, EMA, GMP, ICH, ISO) and internal quality standards.

Oversee environmental monitoring programs, including air, water, and surface contamination testing.

Manage contamination control training programs for production and quality personnel.

Collaborate with cross-functional teams to design and maintain cleanroom and controlled environmental standards.

Investigate contamination-related deviations, identify root causes, and implement corrective and preventive actions (CAPAs).

Optimize cleaning and disinfection procedures to ensure a high standard of facility hygiene.

Stay updated with industry trends, new technologies, and regulatory updates related to contamination control.

Provide subject matter expertise during audits and regulatory inspections.

Qualifications & Requirements :

Bachelor’s or master’s degree in microbiology, Biotechnology, Biochemistry, or a related field.

Minimum of 5 years of experience in contamination control, environmental monitoring, or quality assurance in the biopharmaceutical industry.

Strong knowledge of GMP regulations and industry best practices in microbial control.

Experience with risk assessment tools, CAPA processes, and validation protocols.

Excellent problem-solving, analytical, and communication skills.

Ability to lead cross-functional teams and train personnel effectively.

Strong attention to detail and commitment to maintaining high-quality standards.

Preferred Qualifications :

Experience in aseptic processing and sterile manufacturing environments.

Experience in Biologics manufacturing GMP.

Certification in contamination control or microbiological quality assurance.

Familiarity with digital monitoring and data analytics tools for contamination tracking.

Working Conditions :

Proactive and continuous improvement mindset.

Operational Excellence knowledge is a plus

Interaction with various departments, including Quality, Manufacturing, Engineering, and Regulatory teams on all sites of mAbxience.

Travel (25%) may be required for improvement opportunities, audits, inspections, and training sessions.

Location can be either Argentina, León or Madrid.

Mabxience is a company committed to equal opportunities, and therefore, all candidates will be considered without distinction of race, color, gender, age, sexual orientation, religion, origin, marital status, citizenship, or disability.