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QC & Tech Transfer Manager in León

Hybrid in León·Added 19 days ago (last checked 2 Nov)

Agency

Onhunters

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Our summary

Work mode: Hybrid, León
Spanish: Fluent
English: Required
Experience: 5+ years
Education: University degree

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Skills

Onhunters is hiring for this role in several places. This vacancy is in León.

This job advert was originally written in Spanish.

Requirements

What we're looking for

University degree in Pharmacy, Chemistry, Biology, Biotechnology, Chemical Engineering or a related scientific discipline.
More than 5 years of experience in Quality Control management positions in the pharmaceutical, biotechnological industry, or GMP environments.
Experience in coordination or leadership of technical, analytical, or quality projects.
Experience in regulated environments and GMP documentation management.
Knowledge of data integrity and pharmaceutical quality systems, including deviations, CAPA, change control, OOS/OOT, and risk management.
High level of Spanish and English, both oral and written.
Technical rigor, analytical capacity, and decision-making based on data and risks.

Nice to have

Complementary training in project management, pharmaceutical quality, applied statistics, or validation.
Experience in laboratory investigations, change management, and audits.
Experience coordinating projects with multiple areas and international stakeholders.

The role

At onhunters, we are looking for a QC Manager to join the Quality area of a company in the pharmaceutical and biotechnological sector, located in León.

The position will report directly to the Head/Director of Quality Control and will have responsibility over a team of approximately 40 people, leading and coordinating projects linked to the Quality Control area in a highly regulated environment.

What you'll do

Your mission will be to lead the planning, execution, and monitoring of Quality Control area projects, ensuring compliance with GMP standards, regulatory requirements, and quality, deadline, and cost objectives. You will act as a link between QC and the various areas involved in development projects, technology transfer, validation, new product introduction, capacity expansions, and activities for CDMO clients.

📋 Your main responsibilities will be

Lead the planning and execution of QC projects, guaranteeing the availability of resources, analytical methods, equipment, materials, and documentation.
Define and monitor work plans, schedules, milestones, risks, and deliverables.
Coordinate the involved QC teams, including analytical development, physicochemical control, microbiology, stability, and sample management.
Guarantee compliance with GMP, internal procedures, and regulatory requirements in analytical activities.
Participate in analytical transfer, method validation, process validation, comparability, and stability studies projects.
Identify quality, capacity, and compliance risks, defining and driving mitigation plans.
Supervise deviations, OOS/OOT, CAPAs, change controls, and investigations that may affect projects.
Drive continuous improvement, digitalization, and process optimization initiatives.
Contribute to the preparation and handling of regulatory audits and inspections related to QC activities.

About Onhunters

Onhunters is a recruitment and staffing agency based in Madrid, Spain, specializing in connecting companies with qualified professionals across a wide range of sectors, including healthcare, engineering, industrial maintenance, renewable energy, and commercial roles. With a portfolio of 48 open positions in Spain, the agency serves both local and international employers, offering services from direct recruitment to executive search and temporary staffing.

As a Spanish-founded company, Onhunters has a strong presence in Madrid and operates across various regions in Spain, including Galicia, Valencia, and the Basque Country. For international professionals, Onhunters offers opportunities to work in Spain's growing job market, particularly in high-demand fields like medicine, engineering, and renewable energy. The agency's focus on matching candidates with roles across the country makes it a relevant partner for those seeking to relocate and work in Spain.