1 день назад
Site Quality Head
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Site Quality Head (Pharmaceutical Quality): Leading QA and QC functions at a pharmaceutical CDMO site with an accent on GMP, ISO 13485, regulatory compliance, and product quality. Focus on managing quality strategy, audits, inspections, technology transfers, departmental resources, and continuous improvement across site operations.
Location: Barberà del Vallès, Spain; onsite role
Company
is a global pharmaceutical CDMO developing and manufacturing APIs and finished dosage forms across 16 sites on three continents.
What you will do
- Lead and manage the site's Quality Assurance and Quality Control departments.
- Ensure site-wide compliance with GMP, ISO 13485, ICH guidelines, the Quality Manual, SOPs, and applicable regulatory requirements.
- Own the site Quality Strategy and Quality Plan, driving continuous improvement and alignment with corporate objectives.
- Act as the primary contact for Global Quality matters and serve as the Medical Devices Management Representative under ISO 13485.
- Manage departmental operations, projects, policies, budgets, and human and financial resources.
- Provide accountability for product quality, patient safety, regulatory compliance, SHE standards, and MRP II Class A performance.
Requirements
- Pharmacy degree; an MBA is valued.
- Advanced English and the local language required.
- Knowledge of FDA, MHRA, EMA, WHO, GxP, and ICH regulations.
- Strongly preferred experience in a pharmaceutical CDMO environment.
- Required exposure to customer audits, regulatory inspections, technology transfers, and multi-client management.
- Experience managing large teams.
Culture & Benefits
- Annual bonus.
- Company car and free parking.
- Subsidized onsite canteen or restaurant ticket, including when working from home.
- Medical, life, and accident insurance.
- Access to Club discounts and offers across more than 400 services.
- Collaborative environment with opportunities for professional growth and long-term development.
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