Solutia Life Sciences is the recruitment division of Solutia, specializing in technical and middle management roles within the pharmaceutical, biotech, and medical device sectors.
We are currently supporting a clinical-stage biotech company in Barcelona in their search for a Quality Assurance Manager to lead and develop their QA function.
The QA Manager will oversee all aspects of the Quality Management System (QMS) to ensure compliance with GCP and regulatory standards (FDA, EMA, ICH).
You will collaborate cross-functionally and play a key role in safeguarding the integrity of clinical data.
Key Responsibilities:
Quality Systems & Compliance
* Improve and maintain the QMS in line with applicable standards
* Develop and implement Quality Risk Management (QRM) processes
* Ensure compliance with ICH-GCP and global regulations
Audits & Inspections
* Develop and execute the clinical audit program (CROs, vendors, TMFs, etc.)
* Lead internal and external audits
* Prepare and support regulatory inspections (FDA, EMA), including CAPAs
Documentation & Oversight
* Review and approve clinical documentation (protocols, ICFs, CSRs, etc.)
* Manage deviations, CAPAs, change control, document control, and training
* Track and report on quality metrics
Collaboration & Leadership
* Work closely with Clinical Ops, PV, RA, Data Mgmt, Manufacturing & Supply Chain
* Provide QA guidance to internal teams
* Promote GxP training and quality culture company-wide
What They Offer:
* Permanent contract
* Hybrid work: 3 days in-office / 2 days remote
* Flexible schedule: Core availability required between 10 a.m and 4 p.m
* Competitive salary
Requirements:
* Bachelor’s or Master’s in Life Sciences, Pharmacy, Biology, Chemistry, or related field
* Certification in Quality Assurance or similar (desirable)
* 6+ years in Clinical Quality Assurance (biotech, pharma, or CRO)
* Strong background in GCP audits (sites, systems, vendors, TMFs)
* Experience managing regulatory inspections
* Solid understanding of ICH-GCP, EMA & FDA regulations
* Familiar with Quality Risk Management (QRM)
* Deep knowledge of clinical trial documentation & data integrity
Skills:
* Analytical & problem-solving mindset
* Strong organizational skills & attention to detail
* Excellent communication & interpersonal abilities
* Able to work independently and in cross-functional teams
Compromiso con la Igualdad de Oportunidades:En Solutia GHS garantizamos que todos nuestros procesos de selección se desarrollan en base a criterios objetivos, valorando únicamente las competencias, la experiencia y el talento de las personas candidatas.Promovemos la igualdad de oportunidades y no toleramos ningún tipo de discriminación por razón de sexo, género, edad, origen, raza, religión, orientación sexual, identidad de género, discapacidad o cualquier otra circunstancia personal o social.Asimismo, nuestra política retributiva se rige por el principio de equidad salarial ante el desempeño de las mismas funciones, reforzando nuestro compromiso con un entorno laboral diverso, inclusivo y respetuoso.