Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.
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We are seeking an experienced Quality Assurance & Compliance Project Manager in Barcelona or Madrid (Spain) to support our pharmaceutical clients in ensuring compliance with integral regulatory requirements and driving continuous improvement of Quality Management Systems (QMS).
Responsibilities
Manage, maintain, and improve Quality Management Systems (QMS) in compliance with GMP regulations and applicable regulatory requirements (EU GMP, FDA, ICH).
Support clients in QMS implementation, remediation, and continuous improvement initiatives.
Coordination and implementation of Contamination Control Strategies (CCS) of Annex 1.
Participate in internal audits, supplier audits, mock inspections, and regulatory inspections.
Manage and support quality processes including Deviations, CAPAs, Change Controls, Complaints, OOS/OOT investigations, Product Quality Reviews (PQR/APR), Batch Record Review, Documentation Management.
Coordinate and support Validation activities, define validation strategies,



acceptance criteria, and sampling plans.
Support Technology Transfer projects between manufacturing sites and external partners.
Participate in remediation activities resulting from inspections by regulatory authorities.
Assist in the preparation and review of responses to regulatory observations and commitments.
Participate in Quality Risk Management initiatives, including process risk assessments and cross-contamination risk assessments.
Requirements
Bachelor's Degree in a scientific discipline such as Pharmaceutical Chemistry (CTF), Pharmacy, Chemistry, Biotechnology, Biology, Microbiology, Pharmaceutical Sciences, or related fields.5–10 years of experience in Quality Assurance, Quality Compliance, or Validation roles within the pharmaceutical industry and/or GMP consulting environments.
Strong knowledge of Quality Management Systems (QMS), GMP regulations, Process Validation, and Cleaning Validation.
Thorough understanding of Annex 1 requirements and their operational implementation.
Proven experience managing deviations, CAPAs, change controls, and quality investigations.
Experience supporting inspection readiness activities and regulatory audits.
Excellent knowledge of EU GMP guidelines, ICH standards, and FDA expectations.
Native in Spanish and fluent in English (minimum B2 level).
Salary starts from 35.000€ gross per year

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