Overview
Deputy Qualified Person (QP) & Regulatory Affairs specialist. CDMO. Spain. Jobs in Madrid, Community of Madrid, Spain at Villarroel & Hunter
Title: Deputy Qualified Person (QP) & Regulatory Affairs specialist. CDMO. Spain.
Company: Villarroel & Hunter
Location: Madrid, Community of Madrid, Spain
We are currently leading the search for a Deputy Qualified Person (QP) & Regulatory Affairs specialist for a top-tier European CDMO specializing in the development and contract manufacturing of biopharmaceuticals (proteins, vaccines, and advanced therapies).
This role serves as the ultimate technical authority and ethical guarantor within the facility, assuming legal responsibility for batch release and regulatory compliance in a high-innovation environment.
Core Mission: To serve as a technical authority before health regulatory bodies (AEMPS/EMA), certifying that every batch of biological medicinal products has been manufactured and controlled in strict accordance with current legislation and Good Manufacturing Practices (GMP).
Key Responsibilities:
- Batch Certification & Release: Ensure, prior to being placed on the market, that each batch complies with the provisions of its marketing authorization or clinical protocol.
- Regulatory Liaison: Act as the main point of contact for health authority inspections and international client audits.
- Quality System Management: Oversee the integrity of the pharmaceutical quality management system, including risk management, deviations, CAPAs, and validations.
- Biotech Process Oversight: Validate that facilities and manufacturing processes (cell culture, purification, fill & finish) operate under strict regulatory compliance.
- Supply Chain Integrity: Supervise the chain of custody for raw materials and finished products to ensure purity and efficacy.
Mandatory Requirements
- Academic Background (according to Directive 2001/83/EC): Official university degree of at least four years of theoretical and practical study. Disciplines: Pharmacy, Medicine, Veterinary Medicine, Chemistry, Pharmaceutical Chemistry and Technology, or Biology.
- Experience: Minimum of 2 to 5 years of practical experience in qualitative and quantitative analysis of medicinal products, as well as necessary testing and checks to ensure quality within a manufacturing authorization holder company.
- Proven expertise in:
Initial and advanced GMP environments.
Occupational Risk Prevention and Biosafety protocols.
Practical application and management of SOPs / PNTs.
Regulatory Affairs
- Languages: English C1 level (essential for the company’s global environment). Spanish is a plus.
- Competencies: Scientific rigor, ethical integrity, technical leadership, and strategic decision-making skills.
What’s in it for you?
- A high-impact role in a leading-edge scientific organization.
- Exposure to international projects with the world's most innovative pharma and biotech companies.
- Competitive compensation package reflecting the legal responsibility of the position.
Location: North Spain. It is not located in Madrid or Barcelona. For further details, we will contact you to tell you the exact location.
