Senior Quality Assurance Lead - GCP Expert

Solutia; Barcelona; Híbrido; EUR 50.000 - 70.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Fixed contract

Hybrid position – 3 days in office, 2 days home

Flexible entry hours

Descripción de la vacante

A life sciences recruitment firm is seeking a Senior Quality Assurance Lead in Barcelona. The role involves overseeing compliance with regulatory requirements and managing the Quality Management System. Candidates should have a degree in Life Sciences and at least 6 years of experience in clinical quality assurance, with strong skills in managing audits and inspections. This position offers a hybrid working model and flexible hours.

Formación

• Minimum 6 years of experience in clinical quality assurance.
• Strong experience conducting GCP audits and managing inspections.
• Understanding of clinical trial documentation and data integrity.

Responsabilidades

• Lead and oversee the Quality Management System (QMS).
• Implement quality assurance systems and conduct audits.
• Support regulatory inspections and manage CAPA processes.

Conocimientos

In-depth knowledge of ICH-GCP

Strong analytical skills

Effective communication skills

Organizational skills

Independent working ability

Educación

Bachelor’s or Master’s degree in Life Sciences

Certification in quality assurance

Descripción del empleo

Senior Quality Assurance Lead - GCP Expert

Join to apply for the Senior Quality Assurance Lead - GCP Expert role at Solutia

Solutia Life Sciences (recruitment division of Solutia) specializes in technical and middle management profiles in the pharmaceutical, biotech, and medical device sectors.

We are currently looking for a Senior QA specialized in GCP for a clinical‑stage biotech company, located in Barcelona.

Purpose of the job

The Quality Assurance Manager will lead and oversee all aspects of the Quality Management System (QMS) to ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH) and internal standards.

The position requires close collaboration with various departments to implement quality assurance systems, conduct audits, and drive improvements. It is essential for maintaining the integrity of clinical data.

Major accountabilities

• Improve and maintain the Quality Management System (QMS) in compliance with applicable regulations and standards.
• Develop, implement and maintain a Quality Risk Management (QRM) process to identify, assess, control, communicate, mitigate and review risks according to standards and regulatory requirements.
• Develop, implement and maintain the clinical audit program based on risk assessment.
• Ensure adherence to Good Clinical Practice (GCP) guidelines.
• Support the development, review and approval of quality‑related documentation, including SOPs, batch records, and validation protocols.
• Lead internal and external audits (investigator sites, CROs, vendors, TMFs, internal systems, etc.).
• Support regulatory inspections (FDA, EMA), including preparation, hosting, CAPA responses, and follow‑up.
• Manage CAPA (Corrective and Preventive Actions), deviations, change control, and risk management processes.
• Oversee document control, training programs, and quality metrics reporting.
• Review and approve clinical trial documentation, including protocols, informed consent forms, monitoring plans, and clinical study reports.
• Collaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and Data Management to ensure quality is embedded across all clinical activities.
• Provide expert QA guidance and oversight to clinical development teams and functions (e.g., Clinical Operations, Pharmacovigilance, Medical Affairs).
• Educate clinical staff on regulatory requirements, quality standards and good practices.
• Collaborate in GxP training activities across the organization.
• Stay current with evolving GCP regulatory requirements and interpret their impact on internal processes and trials.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, and Supply Chain to ensure quality is integrated throughout the product lifecycle.

Requirements

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biology, Chemistry, or a related field.
• Certification in quality assurance or a related field.
• Minimum 6 years of experience in clinical quality assurance in the biotech, pharmaceutical, or CRO industry.
• In‑depth knowledge of ICH‑GCP, EMA and FDA regulations, and global clinical trial processes and requirements.
• Ability to interpret regulations and provide pragmatic, risk‑based QA guidance.
• Familiarity with Quality Risk Management (QRM) approach.
• Strong experience conducting GCP audits (sites, systems, vendors, TMFs) and managing regulatory inspections.
• Strong understanding of clinical trial documentation and data integrity principles.
• Excellent analytical and problem‑solving skills.
• Effective communication and interpersonal skills.
• Strong organizational skills; ability to manage multiple priorities, attention to detail.
• Ability to work independently and as part of a team.

Benefits

• Fixed contract.
• Hybrid position – 3 days in office – 2 days home.
• Flexible entry hours.

Seniority level

Mid‑Senior level.

Employment type

Full‑time.

Job function

Project Management and Quality Assurance.

Industries

Biotechnology Research, Pharmaceutical Manufacturing, and Hospitals and Health Care.

Referrals increase your chances of interviewing at Solutia by 2x.

Get notified about new Quality Expert jobs in Barcelona, Catalonia, Spain.