Requirements: English
Company: Fundaci Privada Mn Clnic Barcelona
Region: Barcelona , Catalonia
Responsibilities:
As our QA Manager, you will be ultimately responsible for ensuring BCCCs Quality Management System (QMS) complies with GCP standards, regulatory requirements, and client expectations. You will lead the design, implementation, and continuous improvement of quality processesincluding cloud-based digital tools. Key responsibilities include:
- Maintain and oversee the QMS in line with GCP, EMA, FDA, ISO, and GDPR standards.
- Manage deviations, CAPAs, risk assessments, and both internal and external audits.
- Coordinate computerized systems validation, training programs, and vendor qualification.
- Act as a GCP compliance advisor for both internal teams and clients.
- Lead a team of QA Officers and host regulatory inspections (AEMPS, EMA, FDA).
Requirements:
- 6+ years in clinical research (drugs or medical devices), 4+ years in Clinical QA.
- 2+ years as the main QA lead (Manager, Director, or equivalent).
- Proven experience hosting regulatory inspections.
- Degree in Life or Applied Sciences, with postgraduate training in Clinical Research and/or QA Management.
- Advanced English (spoken & written) and Spanish. Catalan is a plus.
- Proficient in cloud-based tools (Microsoft 365, Google Workspace).
Valuable:
- Strong knowledge of GCP (EMA/AEMPS/FDA), GDPR, and relevant ISO standards.
- Strategic thinking, strong problem-solving and decision-making skills.
- Excellent communication and teamwork abilities.
Working conditions:
- Full time position
- Hybrid (on-site & remote)
- Offices located in the center of Barcelona
- Competitive salary range
- Benefits Club