Overview
QA / Quality Director Jobs in Montgat, Catalonia, Spain at Setonda Laboratorio
Title: QA / Quality Director
Company: Setonda Laboratorio
Location: Montgat, Catalonia, Spain
Company Description Grand Medical Group AG, headquartered in Luzern, Switzerland, has grown over the past 15+ years from a healthcare marketing company into a global manufacturer of pharmaceuticals, food supplements, and natural products. The company focuses on key therapeutic areas including anti-infectives, anti-osteoporosis, central nervous system, cardiovascular, immune-suppressants, gastroenterology, neurology, and urology. It operates three pharmaceutical manufacturing facilities producing capsules, tablets, and injectables, and recently commissioned a state-of-the-art plant in Warsaw, Poland. All facilities are approved by European Union regulatory authorities, supporting high-quality global supply. Grand Medical Group AG actively exports to Asia, Africa, and Europe, with a portfolio of over 75 products and 320 marketing authorizations across these regions.
Key Responsibilities
- Lead and manage the company’s Quality Assurance function in Spain.
- Maintain and continuously improve the Quality Management System in accordance with EU GMP, GDP and applicable regulatory requirements.
- Ensure inspection readiness for regulatory authority inspections, customer audits and internal corporate audits.
- Oversee deviation management, CAPA, change control, risk management and quality event investigations.
- Ensure proper review, approval and lifecycle management of GMP documentation, including SOPs, specifications, batch records, validation documents and quality agreements.
- Support batch release activities by ensuring that all required quality documentation and compliance checks are completed.
- Supervise supplier qualification, contract manufacturer oversight, service provider qualification and periodic supplier performance review.
- Coordinate internal audits and ensure timely follow-up of audit observations and CAPA effectiveness.
- Provide QA oversight for manufacturing, packaging, laboratory, warehouse and distribution-related quality activities.
- Ensure quality compliance for pharmaceutical products, food supplements and other healthcare products within the company portfolio.
- Support regulatory submissions and authority responses from a quality documentation perspective.
- Ensure appropriate training systems are in place for GMP, GDP and quality-related procedures.
- Lead quality review meetings, quality KPIs, trend analysis and management review processes.
- Promote a proactive quality culture based on compliance, accountability, data integrity and continuous improvement.
- Act as a key quality interface with regulatory affairs, production, QC, supply chain, R&D, commercial and external partners.
Required Qualifications
- University degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Life Sciences or a related scientific discipline.
- Minimum 5 years of professional experience in pharmaceutical Quality Assurance, Quality Control, GMP manufacturing or related quality operations.
- Previous experience in a Quality Manager, QA Manager, Head of QA or Quality Director role is strongly preferred.
- Strong knowledge of EU GMP, GDP, quality systems, regulatory inspections and pharmaceutical documentation requirements.
- Experience with deviations, CAPA, change control, validation, supplier qualification, internal audits and quality risk management.
- Good understanding of pharmaceutical manufacturing, packaging, QC laboratory operations and batch documentation flow.
- Experience with food supplements or healthcare products will be considered an advantage.
- Strong leadership, communication, decision-making and cross-functional coordination skills.
- High level of integrity, accountability and attention to detail.
- Fluent English is required.
- Spanish language proficiency is strongly preferred.
- Eligibility to work in Spain.
Preferred Qualifications
- Pharmacist qualification or eligibility for technical / quality responsibility under Spanish or EU regulatory expectations.
- Experience with international markets and export-oriented product portfolios.
- Experience in regulatory authority inspections and customer audits.
- Knowledge of data integrity principles and digital quality systems.
- Previous experience in a multinational or group-level quality environment.
